Effective Antibiotic Treatment of MRSA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00388310
First received: October 13, 2006
Last updated: November 7, 2012
Last verified: November 2012
  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)

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

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. [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388310

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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
Antibiotics, Antitubercular
Sulfamethoxazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 29, 2014