Official Title: “A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: May 2011

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.

Intervention(s) in this Clinical Trial

• Drug: trimethoprim-sulfamethoxazole
  • trimethoprim/sulfamethoxazole 320/1600 mg po bid
• Drug: vancomycin
  • 1g iv bid

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • trimethoprim-sulfamethoxazole
• Active Comparator: 2
  • vancomycin

Primary Measures

• Clinical cure at 12 months
  • Time Frame: 12 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

Timothy H. Dellitt, MD Principal Investigator UW  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00324922

Study ID Number: 27915-B

ClinicalTrials.gov Identifier: NCT00324922

Health Authority: United States: Institutional Review Board