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

Purpose

The purpose of this study is to determine if antibiotics 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 4


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: Abscess Antibiotics Skin Conditions Skin Infections

Drug Information available for: Sulfamethoxazole Trimethoprim Simethicone Trimethoprim hydrochloride

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 [ Time Frame: 10-14 days and 3 month ] [ Designated as safety issue: No ]
The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.


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 Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo. Other Name: Maalox (with simethicone and bitter mixture)
Active Comparator: antibiotic group Trimethoprim-sulfamethoxazole suspension	Drug: Trimethoprim-sulfamethoxazole Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL. Other Name: Septra

Arms

Assigned Interventions

Placebo Comparator: placebo group

Maalox and bitter mixture

Drug: Placebo group

Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

Other Name: Maalox (with simethicone and bitter mixture)

Active Comparator: antibiotic group

Trimethoprim-sulfamethoxazole suspension

Drug: Trimethoprim-sulfamethoxazole

Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.

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 (Child, Adult)
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

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, see Learn About Clinical Studies.

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. doi: 10.1016/j.annemergmed.2007.12.004. 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.

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. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.


Responsible Party:	Myto Duong, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier:	NCT00679302 History of Changes
Other Study ID Numbers:	14415
Study First Received:	May 14, 2008
Results First Received:	January 29, 2013
Last Updated:	March 28, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Louis University:


skin abscess CA-MRSA

Additional relevant MeSH terms:


Abscess Skin Diseases Communicable Diseases Infection Skin Diseases, Infectious Suppuration Inflammation Pathologic Processes Anti-Bacterial Agents Trimethoprim, Sulfamethoxazole Drug Combination Antibiotics, Antitubercular Simethicone Trimethoprim Sulfamethoxazole Aluminum hydroxide, magnesium hydroxide, drug combination	Anti-Infective Agents Antitubercular Agents Antifoaming Agents Molecular Mechanisms of Pharmacological Action Emollients Dermatologic Agents Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016