Status:
COMPLETED
Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis
Lead Sponsor:
University of Washington
Conditions:
Osteomyelitis
Methicillin-resistant Staphylococcus Aureus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) osteomyelit...
Detailed Description
Treatment of osteomyelitis is hampered by a paucity of evidence from prospective clinical trials with randomized treatment arms. Furthermore, previous randomized or observational trials have enrolled ...
Eligibility Criteria
Inclusion
- 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.
- Surgical debridement of infection site, as needed.
- Subject is capable of providing written informed consent.
- Subject is at least 18 years of age.
- Subject capable of receiving outpatient parenteral therapy for 12 weeks.
Exclusion
- Hypersensitivity to TMP-SMX or vancomycin.
- S. aureus resistant to TMP-SMX or vancomycin.
- Osteomyelitis that develops directly from a chronic, open wound.
- 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).
- Subject has a positive pregnancy test at study enrollment.
- Convicted felon currently in prison.
- Baseline renal or hepatic insufficiency that would preclude administration of study drugs.
- Active injection drug use without safe conditions to administer intravenous antibiotics for 3 months.
- Anticipated use of antibiotics for greater than 14 days for an infection other than osteomyelitis.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00324922
Start Date
May 1 2006
End Date
May 1 2007
Last Update
April 11 2023
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98104