Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

NCT02024867 | Completed Results

• 1 other identifier: DB 2456
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Conditions

Skin Disease, Bacterial; Abscess

Keywords

Methicillin resistent Staphylococcus aureus; Staphylococcus aureus

Outcome Measures

Primary Outcomes (3)

• Treatment Failures

  Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.

  up to 2 weeks after surgical drainage

• Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

  Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.

  up to 2 weeks after surgical drainage

• Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

  Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.

  up to 2 weeks after surgical drainage

Secondary Outcomes (3)

• Recurrent Skin Infections

  1 month after surgical drainage

• Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

  1 month after surgical drainage

• Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

  1 month after surgical drainage

Study Arms (2)

10 days of Trimethoprim-Sulfamethoxazole

ACTIVE COMPARATOR

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Drug: Trimethoprim-Sulfamethoxazole

3 days of Trimethoprim-Sulfamethoxazole

EXPERIMENTAL

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Drug: Trimethoprim-Sulfamethoxazole

Interventions

Trimethoprim-Sulfamethoxazole DRUG

3 versus 10 days of drug

Also known as: Septra, Bactrim

10 days of Trimethoprim-Sulfamethoxazole; 3 days of Trimethoprim-Sulfamethoxazole

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
• minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient

You may not qualify if:

• patients requiring immediate hospitalization
• patients who have received 2 or more doses of antibiotics in the previous 36 hours
• patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
• patients with a concurrent, non-abscess infection
• patients with an allergy to Trimethoprim-sulfamethoxazole

Sponsors & Collaborators

• Lucy Holmes, MD: lead
• New York State Department of Health: collaborator
• Women & Children's Hospital of Buffalo: collaborator

Study Sites (1)

Women & Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

Related Publications (3)

• 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 BACKGROUND

• Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.

  PMID: 20346539 BACKGROUND

• Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.

  PMID: 26578074 DERIVED

MeSH Terms

Conditions

Skin Diseases, Bacterial; Abscess; Staphylococcal Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

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

Results Point of Contact

• Title: Dr. Lucy Holmes
• Organization: University at Buffalo

LHolmes@upa.chob.edu

716-878-7277

Study Officials

• Lucy C Holmes, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Howard Faden, MD

  University at Buffalo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: December 31, 2013
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 19, 2015
• Results First Posted: September 15, 2014

Record last verified: 2015-09

Locations

US (1)