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

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.
 
ClinicalTrials.gov Identifier: NCT00324922
Recruitment Status : Unknown
Verified July 2009 by University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : May 11, 2006
Last Update Posted : July 29, 2009
Sponsor:
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE May 9, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date July 29, 2009
Study Start Date  ICMJE May 2006
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
Clinical cure at 12 months [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
Clinical cure at 12 months
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus (MRSA) Osteomyelitis (VOTSMO)
Official Title  ICMJE A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteomyelitis
  • Methicillin-resistant Staphylococcus Aureus
Intervention  ICMJE
  • Drug: trimethoprim-sulfamethoxazole
    trimethoprim/sulfamethoxazole 320/1600 mg po bid
  • Drug: vancomycin
    1g iv bid
Study Arms  ICMJE
  • Active Comparator: 1
    trimethoprim-sulfamethoxazole
    Interventions:
    • Drug: trimethoprim-sulfamethoxazole
    • Drug: vancomycin
  • Active Comparator: 2
    vancomycin
    Intervention: Drug: vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2006)
300
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324922
Other Study ID Numbers  ICMJE 27915-B
05-6396-B 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Harrington, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Washington
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP