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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00388310
Other study ID # 26018
Secondary ID
Status Completed
Phase N/A
First received October 13, 2006
Last updated November 7, 2012
Start date February 2006
Est. completion date December 2008

Study information

Verified date November 2012
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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At our institution, it is estimated that 60-70% (unpublished observation) of cultured abscesses are caused by CA-MRSA.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


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Culture
Culture

Locations

Country Name City State
United States Christiana Care Health Services Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 days No
Primary 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 5 days No
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