Effective Antibiotic Treatment of MRSA
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Purpose
To evaluate the effective duration (in days) to clinical improvement of outpatient antibiotic regimens in the treatment of superficial abscesses caused by MRSA in patients that present to the emergency department.
| Condition | Intervention |
|---|---|
|
Skin Diseases, Infectious |
Procedure: Culture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effective Duration of Antibiotic Treatment of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | February 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cephalexin
Cephalexin 250 mg PO q6h x5 days
|
Procedure: Culture
Culture
|
|
Active Comparator: Clindamycin
Clindamycin 300 mg PO q6h x5 days
|
Procedure: Culture
Culture
|
|
Active Comparator: trimethoprim/sulfamethoxazole
trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days
|
Procedure: Culture
Culture
|
| Placebo Comparator: Placebo |
Procedure: Culture
Culture
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Delaware | |
| Christiana Care Health Services | |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: | Brian Levine, MD | Christiana Care Health Services |
More Information
No publications provided
| Responsible Party: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00388310 History of Changes |
| Other Study ID Numbers: | 26018 |
| Study First Received: | October 13, 2006 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Christiana Care Health Services:
|
cellulitis furuncles carbuncles abscess |
Additional relevant MeSH terms:
|
Communicable Diseases Infection Skin Diseases Skin Diseases, Infectious Anti-Bacterial Agents |
Sulfamethoxazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013