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

January 5, 2021 updated by: Children's Mercy Hospital Kansas City

Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trimethoprim-sulfamethaxazole
Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
Drug: Trimethoprim-sulfamethoxazole
10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
Other Names:
  • Bactrim
Placebo Comparator: Sugar pill
Incision and drainage of the abscess and treatment with oral placebo (100 patients)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Blue Cross Blue Shield

Investigators

  • Principal Investigator: Joan E Giovanni, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0810-162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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