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Effective Antibiotic Treatment of MRSA

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ClinicalTrials.gov Identifier: NCT00388310
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : November 9, 2012
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Procedure: Culture Not Applicable

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At our institution, it is estimated that 60-70% (unpublished observation) of cultured abscesses are caused by CA-MRSA.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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effective Duration of Antibiotic Treatment of Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA)
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT00388310


Locations
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United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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Principal Investigator: Brian Levine, MD Christiana Care Health Services
More Information
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Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00388310    
Other Study ID Numbers: 26018
First Posted: October 16, 2006    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Keywords provided by Christiana Care Health Services:
cellulitis
furuncles
carbuncles
abscess
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Skin Diseases, Infectious
Skin Diseases