Overview

Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus (MRSA) Osteomyelitis (VOTSMO)

Status:
Unknown status
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
The primary question of this study is to understand if trimethoprim-sulfamethoxazole (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Treatments:
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Vancomycin
Criteria
Inclusion Criteria:

1. Culture-proven MRSA, obtained in operating room or sterile biopsy procedure from bone
site. The infection and sampling site can either be within bone or a deep soft-tissue
site that is contiguous with bone; OR radiographic abnormality consistent with
osteomyelitis in conjunction with a positive blood culture for MRSA.

2. Surgical debridement of infection site, as needed.

3. Subject is capable of providing written informed consent.

4. Subject is at least 18 years of age.

5. Subject capable of receiving outpatient parenteral therapy for 12 weeks.

Exclusion Criteria:

1. Hypersensitivity to TMP-SMX or vancomycin.

2. S. aureus resistant to TMP-SMX or vancomycin.

3. Osteomyelitis that develops directly from a chronic, open wound.

4. Polymicrobial culture(the only exception is if coagulase-negative staphylococcus is
present in the culture and the clinical assessment is that it is a contaminant).

5. Subject has a positive pregnancy test at study enrollment.

6. Convicted felon currently in prison.

7. Baseline renal or hepatic insufficiency that would preclude administration of study
drugs.

8. Active injection drug use without safe conditions to administer intravenous
antibiotics for 3 months.

9. Anticipated use of antibiotics for greater than 14 days for an infection other than
osteomyelitis.