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

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ClinicalTrials.gov Identifier: NCT00829686
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : July 28, 2009
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Gillian Schmitz, Wilford Hall Medical Center

Brief Summary:
Patients will be enrolled in a multi-center study 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) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day 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 emergency room (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 or disease Intervention/treatment Phase
Abscess Drug: Septra Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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
Study Start Date : June 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No intervention
No antibiotic
Active Comparator: Septra DS
Septra DS (800/160) two pills PO BID x 7 days
Drug: Septra
(800/125) PO BID X 7 days



Primary Outcome Measures :
  1. Clinical Improvement at 7 Days After Incision and Drainage [ Time Frame: 7 days ]
    improving wound without evidence of fever, worsening cellulitis or induration


Secondary Outcome Measures :
  1. Recurrence Rates [ Time Frame: 30 days ]
    recurrence of abscess in previous or new location within 30 days



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829686


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

Responsible Party: Gillian Schmitz, PI, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT00829686     History of Changes
Other Study ID Numbers: FWH20080055H-Pilot
First Posted: January 27, 2009    Key Record Dates
Results First Posted: July 28, 2009
Last Update Posted: June 9, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Abscess
Staphylococcal Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Methicillin
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents