Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

NCT00679302 | Completed Phase 4 Results DMC

• 1 other identifier: 14415
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Diseases, Infectious

Keywords

skin abscess; CA-MRSA

Outcome Measures

Primary Outcomes (1)

• Skin Abscess Resolution

  10-14 days

Secondary Outcomes (1)

• New Lesion Development and Spread of Skin Abscesses (on Subject)

  10-14 days and 3 month

Study Arms (2)

placebo group

PLACEBO COMPARATOR

Maalox and bitter mixture

Drug: Placebo group

antibiotic group

ACTIVE COMPARATOR

Trimethoprim-sulfamethoxazole suspension

Drug: Trimethoprim-sulfamethoxazole

Interventions

Trimethoprim-sulfamethoxazole DRUG

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.

Also known as: Septra

antibiotic group

Placebo group DRUG

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

Also known as: Maalox (with simethicone and bitter mixture)

placebo group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Related Publications (5)

• 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.

  PMID: 18222564 BACKGROUND

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

  PMID: 17934031 BACKGROUND

• Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70. doi: 10.2165/00128071-200708050-00001.

  PMID: 17902728 BACKGROUND

• 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. doi: 10.1097/01.inf.0000109288.06912.21.

  PMID: 14872177 BACKGROUND

• 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.

  PMID: 19409657 DERIVED

MeSH Terms

Conditions

Skin Diseases, Infectious

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; aluminum hydroxide, magnesium hydroxide, drug combination

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Small sample size with large number of loss to follow up at the 3 month mark.

Results Point of Contact

• Title: Dr. Myto Duong, Pediatric Emergency Medicine Director
• Organization: Southern Illinois University, School of Medicine

myto_duong@yahoo.com

217-545-7409

Study Officials

• John Peter, MD

  St. Louis University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: July 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 4, 2018
• Results First Posted: April 29, 2014

Record last verified: 2014-03

Locations

US (1)