Utility of Trimethoprim-Sulfamethoxazole Use in Skin Abscess Management - Full Text View

Sponsor:	St. Louis University
Information provided by:	St. Louis University
ClinicalTrials.gov Identifier:	NCT00679302

Purpose

The purpose of this study is to determine if antibiotica are required in the management of skin abscess following incision and drainage.

Condition	Intervention	Phase
Skin Diseases, Infectious	Drug: Trimethoprim-sulfamethoxazole Drug: Placebo group	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Skin Conditions Skin Infections

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:

skin abscess resolution [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

new lesion development and spread of skin abscesses/infection to other family members [ Time Frame: 10-14 days and 3 month ] [ Designated as safety issue: No ]

Enrollment:	161
Study Start Date:	July 2006
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo group Maalox and bitter mixture	Drug: Placebo group simethicone and bitter mixture Other Name: Maalox
Active Comparator: antibiotic group Trimethoprim-sulfamethoxazole suspension	Drug: Trimethoprim-sulfamethoxazole Trimethoprim-sulfamethoxazole suspension 10-12mg/kg/day divided twice daily for 10 days Other Name: Septra

Detailed Description:

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Eligibility

Ages Eligible for Study:	3 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

non-toxic patients
immunocompetent patients
3 months to 18 years old
English-speaking patients
skin abscesses
not on antibiotics

Exclusion Criteria:

toxic patients
immunocompromising co-morbidities
less than 3 months old or older than 18 years of age
non-english speaking
on antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679302

Locations

United States, Missouri
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104

Sponsors and Collaborators

St. Louis University

Investigators

Study Director:

John Peter, MD

St. Louis University

More Information

Publications:

Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008 Mar;51(3):291-8. Epub 2008 Jan 28.

Korownyk C, Allan GM. Evidence-based approach to abscess management. Can Fam Physician. 2007 Oct;53(10):1680-4. Review.

Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70. Review.

Lee MC, Rios AM, Aten MF, Mejias A, Cavuoti D, McCracken GH Jr, Hardy RD. Management and outcome of children with skin and soft tissue abscesses caused by community-acquired methicillin-resistant Staphylococcus aureus. Pediatr Infect Dis J. 2004 Feb;23(2):123-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. Epub 2009 May 5.

Responsible Party:	Myto Duong, St Louis University, Cardinal Glennon Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00679302 History of Changes
Other Study ID Numbers:	14415
Study First Received:	May 14, 2008
Last Updated:	May 14, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Louis University:

skin abscess
CA-MRSA

Additional relevant MeSH terms:

Abscess
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Suppuration
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012