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Trial record 6 of 231 for:    clindamycin

Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

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ClinicalTrials.gov Identifier: NCT01619410
Recruitment Status : Terminated (slow accrual)
First Posted : June 14, 2012
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Skin Diseases, Bacterial
Abscess
Interventions Biological: Linezolid
Biological: Clindamycin
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description Linezolid: Linezolid 600 mg every 12 hours for 7 days Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Period Title: Overall Study
Started 14 11
Completed 7 7
Not Completed 7 4
Reason Not Completed
Lost to Follow-up             7             4
Arm/Group Title Linezolid Clindamycin Total
Hide Arm/Group Description Linezolid: Linezolid 600 mg every 12 hours for 7 days Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days Total of all reporting groups
Overall Number of Baseline Participants 14 11 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 11 participants 25 participants
43.3  (15.4) 40.5  (11.9) 42.0  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Female
7
  50.0%
10
  90.9%
17
  68.0%
Male
7
  50.0%
1
   9.1%
8
  32.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
14
 100.0%
11
 100.0%
25
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  92.9%
11
 100.0%
24
  96.0%
White
1
   7.1%
0
   0.0%
1
   4.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 11 participants 25 participants
14 11 25
1.Primary Outcome
Title The Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Hide Description Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.
Time Frame 40 days after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects returning for the 40-day outcome measurement were included in this analysis
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description:
Linezolid: Linezolid 600 mg every 12 hours for 7 days
Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Number of Participants Analyzed 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
2
  28.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linezolid, Clindamycin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Response of Skin Infections to Treatment -- 7 Days
Hide Description The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time Frame 7 days after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description:
Linezolid: Linezolid 600 mg every 12 hours for 7 days
Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Number of Participants Analyzed 10 7
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
10
 100.0%
7
 100.0%
Treatment failure
0
   0.0%
0
   0.0%
Relapse
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Clinical Response of Skin Infections to Treatment -- 40 Days
Hide Description The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time Frame 40 days after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description:
Linezolid: Linezolid 600 mg every 12 hours for 7 days
Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
9
 100.0%
6
  85.7%
Treatment failure
0
   0.0%
0
   0.0%
Relapse
0
   0.0%
1
  14.3%
4.Secondary Outcome
Title The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
Hide Description The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.
Time Frame 40 days after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data available due to samples being lost as a result of equipment issues.
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description:
Linezolid: Linezolid 600 mg every 12 hours for 7 days
Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 40 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Linezolid Clindamycin
Hide Arm/Group Description Linezolid: Linezolid 600 mg every 12 hours for 7 days Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days
All-Cause Mortality
Linezolid Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Linezolid Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linezolid Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
The anticipated enrollment of 152 subjects wasn't achieved. There was slower accrual because the epidemiology of S. aureus infections changed & fewer eligible patients presented. Thus, the study is underpowered for the primary outcome.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Michael Z. David/Assistant Professor
Organization: University of Pennsylvania
Phone: 215-662-6932
EMail: michdav@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01619410     History of Changes
Other Study ID Numbers: 11-0550
First Submitted: June 12, 2012
First Posted: June 14, 2012
Results First Submitted: July 3, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019