Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00730028
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Staphylococcal Infection
Interventions Drug: Trimethoprim-sulfamethoxazole
Other: Placebo
Drug: Clindamycin
Enrollment 1310
Recruitment Details Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015
Pre-assignment Details  
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Period Title: Overall Study
Started 264 260 266 263 257
Completed 204 194 221 207 175
Not Completed 60 66 45 56 82
Reason Not Completed
Adverse Event             23             26             16             20             43
Lost to Follow-up             13             26             22             26             25
Protocol Violation             6             1             1             2             0
Withdrawal by Subject             9             5             4             5             9
Physician Decision             3             3             2             3             2
Treatment Failure             5             5             0             0             1
Randomization Error             1             0             0             0             2
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess – Clindamycin Limited Abscess - TMP-SMX Limited Abscess – Placebo Total
Hide Arm/Group Description Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily. Total of all reporting groups
Overall Number of Baseline Participants 264 260 266 263 257 1310
Hide Baseline Analysis Population Description
All participants enrolled in the protocol are included in the baseline analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 264 participants 260 participants 266 participants 263 participants 257 participants 1310 participants
<=18 years
81
  30.7%
74
  28.5%
101
  38.0%
91
  34.6%
89
  34.6%
436
  33.3%
Between 18 and 65 years
181
  68.6%
184
  70.8%
164
  61.7%
169
  64.3%
166
  64.6%
864
  66.0%
>=65 years
2
   0.8%
2
   0.8%
1
   0.4%
3
   1.1%
2
   0.8%
10
   0.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 264 participants 260 participants 266 participants 263 participants 257 participants 1310 participants
26.8  (17.2) 27.5  (16.9) 24.8  (17.8) 25.6  (18.1) 26.2  (18.7) 27.1  (17.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 264 participants 260 participants 266 participants 263 participants 257 participants 1310 participants
Female
129
  48.9%
121
  46.5%
126
  47.4%
111
  42.2%
101
  39.3%
588
  44.9%
Male
135
  51.1%
139
  53.5%
140
  52.6%
152
  57.8%
156
  60.7%
722
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 264 participants 260 participants 266 participants 263 participants 257 participants 1310 participants
264 260 266 263 257 1310
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
Hide Description

Clinical failure is defined as the occurence of any of the following:

  1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
  2. Occurrence of a SSTI at another site other than the site(s) under study.
  3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
  4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
  5. Unplanned surgical procedure for the infection under study at any time through the TOC visit.
  6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Time Frame Test of cure (TOC) (7-10 days after completion of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 237 229 238 232 220
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.5
(85.2 to 93.7)
88.2
(83.7 to 92.7)
92.9
(89.3 to 96.4)
92.7
(89.0 to 96.3)
80.5
(74.8 to 86.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7688
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-7.6 to 5.1
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-5.4 to 5.1
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.4
Confidence Interval (2-Sided) 95%
-19.2 to -5.6
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.2
Confidence Interval (2-Sided) 95%
-19.1 to -5.4
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
2.Primary Outcome
Title Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
Hide Description

Clinical failure is defined as the occurence of any of the following:

  1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
  2. Occurrence of a SSTI at another site other than the site(s) under study.
  3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
  4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
  5. Unplanned surgical procedure for the infection under study at any time through the TOC visit.
  6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Time Frame Test of cure (TOC) (7-10 days after completion of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was comprised of all participants enrolled in the trial.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 264 260 266 263 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.3
(75.2 to 85.4)
77.7
(72.3 to 83.1)
83.1
(78.3 to 87.9)
81.7
(76.8 to 86.7)
68.9
(62.9 to 74.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5200
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-10.2 to 4.9
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7324
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-8.4 to 5.7
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.2
Confidence Interval (2-Sided) 95%
-22.0 to -6.4
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Adjustments for multiple comparisons were made using a Bonferroni correction.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.9
Confidence Interval (2-Sided) 95%
-20.8 to -5.0
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
3.Secondary Outcome
Title Number of Participants Reporting Adverse Events.
Hide Description Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
Time Frame End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 259 258 265 261 255
Measure Type: Number
Unit of Measure: participants
116 132 119 94 119
4.Secondary Outcome
Title Number of Participants Reporting Adverse Events That Are Treatment Limiting.
Hide Description Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
Time Frame End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 259 258 265 261 255
Measure Type: Number
Unit of Measure: participants
1 0 6 3 4
5.Secondary Outcome
Title Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
Hide Description Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Time Frame EOT visit within 48 hours of completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 240 222 231 223 219
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.2
(85.0 to 93.3)
88.3
(83.8 to 92.7)
90.9
(87.0 to 94.8)
94.2
(90.9 to 97.5)
84.9
(80.0 to 89.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7707
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-7.1 to 5.3
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2141
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-2.0 to 8.5
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0593
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-12.4 to 0.5
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-15.3 to -3.1
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
6.Secondary Outcome
Title Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
Hide Description Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Time Frame EOT visit within 48 hours of completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the trial.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 264 260 266 263 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.1
(76.1 to 86.0)
75.4
(70.0 to 80.8)
78.9
(73.9 to 84.0)
79.8
(74.8 to 84.9)
72.4
(66.7 to 78.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1381
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-13.1 to 1.8
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8302
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-6.4 to 8.2
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0838
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.6
Confidence Interval (2-Sided) 95%
-14.3 to 1.1
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0507
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.5
Confidence Interval (2-Sided) 95%
-15.2 to 0.2
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
7.Secondary Outcome
Title Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
Hide Description Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Time Frame OMFU visit
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 230 225 234 226 218
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.9
(78.9 to 88.9)
78.2
(72.6 to 83.8)
89.3
(85.1 to 93.5)
85.0
(80.1 to 89.8)
73.9
(67.8 to 79.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1505
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-13.3 to 1.9
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1666
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-10.9 to 2.2
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.5
Confidence Interval (2-Sided) 95%
-23.0 to -8.0
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-19.0 to -3.2
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
8.Secondary Outcome
Title Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
Hide Description Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Time Frame OMFU visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the trial.
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess - Clindamycin Limited Abscess - TMP-SMX Limited Abscess - Placebo
Hide Arm/Group Description:
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
Overall Number of Participants Analyzed 264 260 266 263 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.1
(67.6 to 78.6)
67.7
(61.8 to 73.6)
78.6
(73.5 to 83.7)
73.0
(67.4 to 78.6)
62.6
(56.5 to 68.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cellulitis or Larger Abscess - Clindamycin, Cellulitis or Larger Abscess - TMP-SMX
Comments Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1815
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-13.6 to 2.8
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - TMP-SMX
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1552
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-13.2 to 2.1
Estimation Comments The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Limited Abscess - Clindamycin, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.9
Confidence Interval (2-Sided) 95%
-24.0 to -7.8
Estimation Comments The mean difference is determined by the cure rate of Placebo minus Clindamycin.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Limited Abscess - TMP-SMX, Limited Abscess - Placebo
Comments Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0145
Comments Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-18.7 to -2.0
Estimation Comments The mean difference is determined by the cure rate of Placebo minus TMP-SMX.
Time Frame Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess – Clindamycin Limited Abscess - TMP-SMX Limited Abscess – Placebo
Hide Arm/Group Description Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children. Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
All-Cause Mortality
Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess – Clindamycin Limited Abscess - TMP-SMX Limited Abscess – Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess – Clindamycin Limited Abscess - TMP-SMX Limited Abscess – Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/264 (1.52%)      5/260 (1.92%)      0/266 (0.00%)      6/263 (2.28%)      2/257 (0.78%)    
Gastrointestinal disorders           
Crohn's Disease * 1  0/264 (0.00%)  0 1/260 (0.38%)  1 0/266 (0.00%)  0 0/263 (0.00%)  0 0/257 (0.00%)  0
Vomiting * 1  0/264 (0.00%)  0 0/260 (0.00%)  0 0/266 (0.00%)  0 0/263 (0.00%)  0 1/257 (0.39%)  1
General disorders           
Induration * 1  0/264 (0.00%)  0 1/260 (0.38%)  1 0/266 (0.00%)  0 0/263 (0.00%)  0 0/257 (0.00%)  0
Infections and infestations           
Cellulitis * 1  1/264 (0.38%)  1 2/260 (0.77%)  2 0/266 (0.00%)  0 1/263 (0.38%)  1 0/257 (0.00%)  0
Abscess * 1  1/264 (0.38%)  1 0/260 (0.00%)  0 0/266 (0.00%)  0 2/263 (0.76%)  2 0/257 (0.00%)  0
Perirectal Abscess * 1  1/264 (0.38%)  1 0/260 (0.00%)  0 0/266 (0.00%)  0 0/263 (0.00%)  0 1/257 (0.39%)  1
Pneumonia * 1  0/264 (0.00%)  0 0/260 (0.00%)  0 0/266 (0.00%)  0 0/263 (0.00%)  0 1/257 (0.39%)  1
Injury, poisoning and procedural complications           
Thermal Burn * 1  1/264 (0.38%)  1 0/260 (0.00%)  0 0/266 (0.00%)  0 0/263 (0.00%)  0 0/257 (0.00%)  0
Injury * 1  0/264 (0.00%)  0 0/260 (0.00%)  0 0/266 (0.00%)  0 1/263 (0.38%)  1 0/257 (0.00%)  0
Psychiatric disorders           
Mental Disorder * 1  0/264 (0.00%)  0 1/260 (0.38%)  1 0/266 (0.00%)  0 0/263 (0.00%)  0 0/257 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Status Asthmaticus * 1  0/264 (0.00%)  0 0/260 (0.00%)  0 0/266 (0.00%)  0 1/263 (0.38%)  1 0/257 (0.00%)  0
Skin and subcutaneous tissue disorders           
Drug Eruption * 1  0/264 (0.00%)  0 0/260 (0.00%)  0 0/266 (0.00%)  0 1/263 (0.38%)  1 0/257 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cellulitis or Larger Abscess - Clindamycin Cellulitis or Larger Abscess - TMP-SMX Limited Abscess – Clindamycin Limited Abscess - TMP-SMX Limited Abscess – Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/264 (22.35%)      72/260 (27.69%)      61/266 (22.93%)      52/263 (19.77%)      60/257 (23.35%)    
Gastrointestinal disorders           
Diarrhoea * 1  27/264 (10.23%)  30 28/260 (10.77%)  29 46/266 (17.29%)  48 17/263 (6.46%)  19 20/257 (7.78%)  20
Infections and infestations           
Abscess * 1  21/264 (7.95%)  23 39/260 (15.00%)  43 13/266 (4.89%)  13 29/263 (11.03%)  30 35/257 (13.62%)  36
Cellulitis * 1  16/264 (6.06%)  19 23/260 (8.85%)  26 3/266 (1.13%)  3 6/263 (2.28%)  6 9/257 (3.50%)  12
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry F. Chambers, MD
Organization: San Francisco General Hospital, UCSF
Phone: (415) 206 - 5437
EMail: hchambers@medsfgh.ucsf.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00730028     History of Changes
Other Study ID Numbers: 07-0051
UCSF CA-MRSA
First Submitted: August 7, 2008
First Posted: August 8, 2008
Results First Submitted: February 18, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016