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Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

This study has been completed.
Sponsor:
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00829686
First received: January 26, 2009
Last updated: July 27, 2009
Last verified: June 2009
  Purpose

Patients will be enrolled in a multi-center study (WHMC and BAMC) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bactrim DS (800/160) two tablets PO BID x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the ER on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.


Condition Intervention
Abscess
Drug: Septra

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Clinical Improvement at 7 Days After Incision and Drainage [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence Rates [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No antibiotic
Active Comparator: 2
Septra DS (800/160) two pills PO BID x 7 days
Drug: Septra
(800/125) PO BID X 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

  • patients with diabetes, HIV, cancer or other immunocompromised patients
  • patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables
  • pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment
  • basic Military Trainees will also be excluded from participation
  • patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
  • patients with sulfa allergy will be excluded.
  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: NCT00829686

Locations
United States, Texas
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Sponsors and Collaborators
Wilford Hall Medical Center
  More Information

No publications provided

Responsible Party: Dr. Gillian Schmitz
ClinicalTrials.gov Identifier: NCT00829686     History of Changes
Other Study ID Numbers: FWH20080055H-Pilot
Study First Received: January 26, 2009
Results First Received: June 5, 2009
Last Updated: July 27, 2009
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
abscess
cellulitis
antibiotics
MRSA

Additional relevant MeSH terms:
Abscess
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Infection
Inflammation
Pathologic Processes
Suppuration
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014