NCT00324922

Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 small numbers of subjects and thus often had non-definitive findings. One of the most common causes of osteomyelitis is Staphylococcus aureus. Over the past 10 years, rates of methicillin-resistant S. aureus (MRSA) have risen dramatically. Vancomycin is currently the treatment of choice for treating MRSA. While vancomycin is effective, it is only available in intravenous formulation and has renal and bone marrow toxicities. There is a critical need for effective, oral, cheap drugs for the treatment of MRSA. Trimethoprim-sulfamethoxazole (TMP-SMX) is a drug with several advantageous properties for the treatment of MRSA osteomyelitis. To address this question regarding optimal treatment of MRSA osteomyelitis, we designed a prospective, randomized trial comparing TMP-SMX with vancomycin for the treatment of MRSA osteomyelitis.

Conditions

• Osteomyelitis
• Methicillin-resistant Staphylococcus Aureus

Interventions

Type	Name	Description
DRUG	trimethoprim-sulfamethoxazole	trimethoprim/sulfamethoxazole 320/1600 mg po bid
DRUG	vancomycin	1g iv bid

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-05-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study