A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis

27915

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.

2006-05-01

2007-05-01

2007-05-01

Completed

Early phase I

2

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-04-11