- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00388310
Effective Antibiotic Treatment of MRSA
Effective Duration of Antibiotic Treatment of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA)
Study Overview
Detailed Description
Skin and soft tissue infections-cellulitis, furuncles, carbuncles, and abscesses-make up approximately 1-2% of emergency room visits annually. While abscesses are generally incised and drained, there is no definite standard treatment regimen or duration of treatment that practitioners have adhered to regarding antibiotic use. Historical evidence suggests that antibiotics may not be necessary for simple superficial abscesses, though a number of antibiotics-including penicillins and cephalosporins-may be used for treatment of large and/or complicated abscesses. These antibiotics however are ineffective against what is becoming an increasingly common pathogen- community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA).
At our institution, it is estimated that 60-70% (unpublished observation) of cultured abscesses are caused by CA-MRSA. These patients have generally been treated with incision and drainage, with the addition of an antibiotic left to the practitioner's discretion. Also, there has been no universally accepted duration of treatment established to observe clinical improvement of such abscesses. Common antibiotic regimens range from 7-14 days of treatment for cellulitic infections. While there has been one prospective trial regarding the use of antibiotics in simple abscesses, there has been no published prospective study on the use of antibiotics in treating CA-MRSA abscesses in adults. Furthermore, while 7-14 days of treatment seems the recommended duration of treating cellulitic infections, no study has evaluated the duration of treatment needed to observe clinical improvement of abscesses caused by CA-MRSA. We wish to prospectively evaluate the duration of treatment necessary to observe clinical improvement of abscesses caused by CA-MRSA among multiple different antibiotics (ie. cephalexin, clindamycin, and trimethoprim/sulfamethoxazole) after standard incision and drainage in patients presenting to the emergency department.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19718
- Christiana Care Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients age 18 and older, presenting to the emergency department with an abscess with a diameter greater than three centimeters
- Informed consent
Exclusion Criteria:
- Patients who are presumed to have community-acquired pathogens
- Under 18
- Abscess less than three centimeters in diameter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Culture
|
|
Active Comparator: Cephalexin
Cephalexin 250 mg PO q6h x5 days
|
Culture
|
|
Active Comparator: Clindamycin
Clindamycin 300 mg PO q6h x5 days
|
Culture
|
|
Active Comparator: trimethoprim/sulfamethoxazole
trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days
|
Culture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the effective duration of treatment of different antibiotic regimens in the treatment of abscess with regards to resolution of patient symptoms and signs.
Time Frame: 5 days
|
5 days
|
|
Treatment failure will be defined as an increase in patient symptoms, increase in abscess size, development of constitutional symptoms, or hospitalization secondary to abscess complications
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26018
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