Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Abscess Drug: Trimethoprim-sulfamethoxazole Drug: Sugar pill Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Actual Study Start Date : March 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

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 Name: 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.




Primary Outcome Measures :
  1. Health Outcomes After Use With Trimethoprim-sulfamethaxazole [ Time Frame: two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867789


Locations
Layout table for location information
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Blue Cross Blue Shield
Investigators
Layout table for investigator information
Principal Investigator: Joan E Giovanni, MD Children's Mercy Hospital Kansas City
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 Posted: March 24, 2009    Key Record Dates
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021
Last Verified: January 2021
Keywords provided by Children's Mercy Hospital Kansas City:
abscess
outcomes
antibiotics
incision and drainage
skin abscess
Additional relevant MeSH terms:
Layout table for MeSH terms
Abscess
Emergencies
Disease Attributes
Pathologic Processes
Suppuration
Infection
Inflammation
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents