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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

Tracking Information
First Submitted Date  ICMJE March 23, 2009
First Posted Date  ICMJE March 24, 2009
Results First Submitted Date  ICMJE August 25, 2020
Results First Posted Date  ICMJE January 26, 2021
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
Health Outcomes After Use With Trimethoprim-sulfamethaxazole [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
The objective of this study is to compare clinical indicators of abscess resolution for two different treatment methods: 1) incision and drainage plus placebo (I&D/P) and 2) incision and drainage plus trimethoprim-sulfamethoxazole (TMP-SMX) (I&D/T-S). [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
Comparison of medication adverse effect profiles between the groups, comparison of outcomes between MRSA isolates versus other pathogens between the groups, and analysis of interrater reliability of physical exam findings for a subgroup of patients. [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
Official Title  ICMJE Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Brief Summary The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abscess
Intervention  ICMJE
  • Drug: Trimethoprim-sulfamethoxazole
    10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
    Other Name: Bactrim
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Trimethoprim-sulfamethaxazole
    Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
    Intervention: Drug: Trimethoprim-sulfamethoxazole
  • Placebo Comparator: Sugar pill
    Incision and drainage of the abscess and treatment with oral placebo (100 patients)
    Intervention: Drug: Sugar pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 5, 2021)
140
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2009)
200
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 3 months to 17 years
  • Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
  • Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion Criteria:

  • Signs of systemic illness or ill-appearing, as determined by the treating physician
  • Admission to the hospital following treatment in the Emergency Department
  • Known sulfa allergy
  • Immunocompromised patients
  • Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
  • Previous antibiotic use (for any reason) in the past seven days
  • Non-English speaking patients and families
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00867789
Other Study ID Numbers  ICMJE 0810-162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Blue Cross Blue Shield
Investigators  ICMJE
Principal Investigator: Joan E Giovanni, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP