Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

• ClinicalTrials.gov Identifier: NCT00679302
• Recruitment Status: Completed
• First Posted: May 16, 2008
• Results First Posted: April 29, 2014
• Last Update Posted: May 4, 2018
• Sponsor: St. Louis University
• Information provided by (Responsible Party): St. Louis University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Skin Diseases, Infectious	Drug: Trimethoprim-sulfamethoxazole; Drug: Placebo group	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: July 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Skin Abscess Resolution [ Time Frame: 10-14 days ]

Secondary Outcome Measures :

1. New Lesion Development and Spread of Skin Abscesses (on Subject) [ Time Frame: 10-14 days and 3 month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Missouri

Cardinal Glennon Children's Medical Center

Saint 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: St. Louis University
• ClinicalTrials.gov Identifier: NCT00679302
• Other Study ID Numbers: 14415
• First Posted: May 16, 2008
• Results First Posted: April 29, 2014
• Last Update Posted: May 4, 2018
• Last Verified: March 2014

Keywords provided by St. Louis University:

skin abscess; CA-MRSA

Additional relevant MeSH terms:

Communicable Diseases; Infections; Abscess; Skin Diseases, Infectious; Skin Diseases; Disease Attributes; Pathologic Processes; Suppuration; Inflammation; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole; Simethicone; 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; Antifoaming Agents; Emollients; Dermatologic Agents; Anti-Bacterial Agents