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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00324922
First received: May 9, 2006
Last updated: July 27, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robert Harrington, University of Washington
ClinicalTrials.gov Identifier: NCT00324922     History of Changes
Other Study ID Numbers: 27915-B, 05-6396-B 01
Study First Received: May 9, 2006
Last Updated: July 27, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 19, 2014