Effective Antibiotic Treatment of MRSA
Primary Purpose
Skin Diseases, Infectious
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culture
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring cellulitis, furuncles, carbuncles, abscess
Eligibility Criteria
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
Sites / Locations
- Christiana Care Health Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Cephalexin
Clindamycin
trimethoprim/sulfamethoxazole
Placebo
Arm Description
Cephalexin 250 mg PO q6h x5 days
Clindamycin 300 mg PO q6h x5 days
trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00388310
First Posted
October 13, 2006
Last Updated
November 7, 2012
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT00388310
Brief Title
Effective Antibiotic Treatment of MRSA
Official Title
Effective Duration of Antibiotic Treatment of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious
Keywords
cellulitis, furuncles, carbuncles, abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cephalexin
Arm Type
Active Comparator
Arm Description
Cephalexin 250 mg PO q6h x5 days
Arm Title
Clindamycin
Arm Type
Active Comparator
Arm Description
Clindamycin 300 mg PO q6h x5 days
Arm Title
trimethoprim/sulfamethoxazole
Arm Type
Active Comparator
Arm Description
trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Culture
Intervention Description
Culture
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Levine, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
12. IPD Sharing Statement
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Effective Antibiotic Treatment of MRSA
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