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Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Abscess

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ClinicalTrials.gov Identifier: NCT01498744
Recruitment Status : Terminated (The study was closed due to poor enrollment and lack of interest.)
First Posted : December 23, 2011
Results First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Abscess Soft Tissue
Methicillin-resistant Staphylococcus Aureus (MRSA) Infection
Skin Abscess
Intervention Drug: Oral Clindamycin
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Period Title: Overall Study
Started 22 31
Completed 22 31
Not Completed 0 0
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic Total
Hide Arm/Group Description

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Total of all reporting groups
Overall Number of Baseline Participants 22 31 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 31 participants 53 participants
<=18 years
22
 100.0%
31
 100.0%
53
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 31 participants 53 participants
Female NA [1]  NA [1]  NA [2] 
Male NA [1]  NA [1]  NA [2] 
[1]
Gender was not collected before this study was closed
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 31 participants 53 participants
22 31 53
1.Primary Outcome
Title Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
Hide Description [Not Specified]
Time Frame At office visit 10-14 days post operation
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that had data collected for this outcome measure are included above.
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description:

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Overall Number of Participants Analyzed 14 19
Measure Type: Number
Unit of Measure: participants
0 1
2.Secondary Outcome
Title Additional Skin and Soft Tissue Infections in Patient
Hide Description The outcome measure was reported by responding to a yes/no
Time Frame Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that had data collected for this outcome measure are included here.
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description:

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Overall Number of Participants Analyzed 14 19
Measure Type: Number
Unit of Measure: participants
10-14 Days(n=14,19) 0 2
90 Day(n=13,15) 2 4
9 Month(n=10,9) 2 3
3.Secondary Outcome
Title Additional Skin or Soft Tissue Infections in Household Contacts
Hide Description [Not Specified]
Time Frame Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that had data collected for this outcome measure are included above.
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description:

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Overall Number of Participants Analyzed 13 19
Measure Type: Number
Unit of Measure: participants
10-14 Days(n=13,19) 0 2
90 Day(n=13,13) 2 4
9 Month(n=9,10) 2 2
4.Secondary Outcome
Title Complication to Antibiotic Regime
Hide Description [Not Specified]
Time Frame Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that had data collected for this outcome measure are included above.
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description:

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Overall Number of Participants Analyzed 14 19
Measure Type: Number
Unit of Measure: participants
10-14 Days(n=14,19) 0 2
90 Day(n=0,0) 0 0
9 Month(n=0,0) 0 0
Time Frame Adverse events were collected throughout the duration of this study. Study started with IRB approval date of February 23, 2010 and was discontinued (last renewal with IRB expired December 13, 2012)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Hide Arm/Group Description

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).

All-Cause Mortality
5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5 Days Postoperative Antibiotic 1 Day Postoperative Antibiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/31 (0.00%) 
Inadequate enrollment numbers leading to early termination of study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katherine A Barsness
Organization: Ann and Robert H. Lurie Children's Hospital of Chicago
Phone: 3122274210
EMail: kbarsness@luriechildrens.org
Layout table for additonal information
Responsible Party: Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01498744     History of Changes
Other Study ID Numbers: IRB # 2010-14118
First Submitted: December 20, 2011
First Posted: December 23, 2011
Results First Submitted: November 11, 2015
Results First Posted: February 25, 2016
Last Update Posted: February 25, 2016