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Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

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ClinicalTrials.gov Identifier: NCT00867789
Recruitment Status : Terminated (Slow enrollment due to subjects not meeting inclusion/exclusion criteria)
First Posted : March 24, 2009
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Blue Cross Blue Shield
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Abscess
Interventions Drug: Trimethoprim-sulfamethoxazole
Drug: Sugar pill
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trimethoprim-sulfamethaxazole Sugar Pill
Hide Arm/Group Description

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

Period Title: Overall Study
Started 70 70
Completed 68 70
Not Completed 2 0
Arm/Group Title Trimethoprim-sulfamethaxazole Sugar Pill Total
Hide Arm/Group Description

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
<=18 years
70
 100.0%
70
 100.0%
140
 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 70 participants 70 participants 140 participants
Female
38
  54.3%
40
  57.1%
78
  55.7%
Male
32
  45.7%
30
  42.9%
62
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 70 participants 140 participants
70 70 140
1.Primary Outcome
Title Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Hide Description [Not Specified]
Time Frame two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trimethoprim-sulfamethaxazole Sugar Pill
Hide Arm/Group Description:

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

Overall Number of Participants Analyzed 70 70
Measure Type: Number
Unit of Measure: Percentage of outcomes assessed
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trimethoprim-sulfamethaxazole Sugar Pill
Hide Arm/Group Description

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.

All-Cause Mortality
Trimethoprim-sulfamethaxazole Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Trimethoprim-sulfamethaxazole Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trimethoprim-sulfamethaxazole Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
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: Dr. Joan Giovanni
Organization: Children's Mercy Hospital
Phone: 8162343430
EMail: gegiovanni@cmh.edu
Publications:
Layout table for additonal information
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00867789    
Other Study ID Numbers: 0810-162
First Submitted: March 23, 2009
First Posted: March 24, 2009
Results First Submitted: August 25, 2020
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021