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Effective Antibiotic Treatment of MRSA

NCT ID: NCT00388310

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-12-31

Brief Summary

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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

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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At our institution, it is estimated that 60-70% (unpublished observation) of cultured abscesses are caused by CA-MRSA.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.

Conditions

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Skin Diseases, Infectious

Keywords

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cellulitis furuncles carbuncles abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cephalexin

Cephalexin 250 mg PO q6h x5 days

Group Type ACTIVE_COMPARATOR

Culture

Intervention Type PROCEDURE

Culture

Clindamycin

Clindamycin 300 mg PO q6h x5 days

Group Type ACTIVE_COMPARATOR

Culture

Intervention Type PROCEDURE

Culture

trimethoprim/sulfamethoxazole

trimethoprim/sulfamethoxazole 160 mg/800 mg PO q12h x 5 days

Group Type ACTIVE_COMPARATOR

Culture

Intervention Type PROCEDURE

Culture

Placebo

Group Type PLACEBO_COMPARATOR

Culture

Intervention Type PROCEDURE

Culture

Interventions

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Culture

Culture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health Services

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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26018

Identifier Type: -

Identifier Source: org_study_id