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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University of Washington.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324922
First Posted: May 11, 2006
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Washington
  Purpose
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.

Condition Intervention
Osteomyelitis Methicillin-resistant Staphylococcus Aureus Drug: trimethoprim-sulfamethoxazole Drug: vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Clinical cure at 12 months [ Time Frame: 12 months ]

Estimated Enrollment: 300
Study Start Date: May 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
trimethoprim-sulfamethoxazole
Drug: trimethoprim-sulfamethoxazole
trimethoprim/sulfamethoxazole 320/1600 mg po bid
Drug: vancomycin
1g iv bid
Active Comparator: 2
vancomycin
Drug: vancomycin
1g iv bid

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324922


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Timothy H. Dellitt, MD UW
Principal Investigator: Jeanne Chan, PharmD, MPH UW
Principal Investigator: Matthew Golden, MD, MPH UW
Principal Investigator: M. Bradford Henley, MD UW
Principal Investigator: Jeanne M Marrazzo, MD, MPH UW
Principal Investigator: Lisa Taitsman, MD UW
Principal Investigator: Thomas R Hawn, MD, PhD UW
Principal Investigator: Robert D Harrington, MD UW
Principal Investigator: Christian Ramers, MD University of Washington
  More Information

Responsible Party: Robert Harrington, University of Washington
ClinicalTrials.gov Identifier: NCT00324922     History of Changes
Other Study ID Numbers: 27915-B
05-6396-B 01
First Submitted: May 9, 2006
First Posted: May 11, 2006
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by University of Washington:
Vancomycin
Trimethoprim-Sulfamethoxazole Combination

Additional relevant MeSH terms:
Staphylococcal Infections
Osteomyelitis
Gram-Positive Bacterial Infections
Bacterial Infections
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Vancomycin
Trimethoprim, Sulfamethoxazole Drug Combination
Trimethoprim
Sulfamethoxazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors


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