Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-Resistant Staphylococcus Aureus (MRSA) Osteomyelitis (VOTSMO)
Information source: University of Washington
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteomyelitis; Methicillin-Resistant Staphylococcus Aureus
Intervention: trimethoprim-sulfamethoxazole (Drug); vancomycin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Timothy H. Dellitt, MD, Principal Investigator, Affiliation: UW
Jeanne Chan, PharmD, MPH, Principal Investigator, Affiliation: UW
Matthew Golden, MD, MPH, Principal Investigator, Affiliation: UW
M. Bradford Henley, MD, Principal Investigator, Affiliation: UW
Jeanne M Marrazzo, MD, MPH, Principal Investigator, Affiliation: UW
Lisa Taitsman, MD, Principal Investigator, Affiliation: UW
Thomas R Hawn, MD, PhD, Principal Investigator, Affiliation: UW
Robert D Harrington, MD, Principal Investigator, Affiliation: UW
Christian Ramers, MD, Principal Investigator, Affiliation: University of Washington
Overall contact:
Robert D. Harrington, MD, Phone: 206-731-5100, Email: rdh@u.washington.edu
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.
Clinical Details
Official title: A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Clinical cure at 12 months
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Robert D. Harrington, MD, Phone: 206-731-5100, Email: rdh@u.washington.edu
University of Washington, Seattle, Washington 98104, United States; Recruiting
Additional Information
Starting date: May 2006
Ending date: May 2011
Last updated: October 30, 2008
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