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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Clinical cure at 12 months
    • Time Frame: 12 months

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Provider of Information About this Clinical Study
    • Robert Harrington, University of Washington
  • Overall Official(s)
    • Timothy H. Dellitt, MD, Principal Investigator, UW
    • Jeanne Chan, PharmD, MPH, Principal Investigator, UW
    • Matthew Golden, MD, MPH, Principal Investigator, UW
    • M. Bradford Henley, MD, Principal Investigator, UW
    • Jeanne M Marrazzo, MD, MPH, Principal Investigator, UW
    • Lisa Taitsman, MD, Principal Investigator, UW
    • Thomas R Hawn, MD, PhD, Principal Investigator, UW
    • Robert D Harrington, MD, Principal Investigator, UW
    • Christian Ramers, MD, Principal Investigator, University of Washington

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