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

Sponsor:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00324922

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis

Resource links provided by NLM:

Drug Information available for: Sulfamethoxazole Trimethoprim Vancomycin Vancomycin hydrochloride Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

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
1: Active Comparator trimethoprim-sulfamethoxazole	Drug: trimethoprim-sulfamethoxazole trimethoprim/sulfamethoxazole 320/1600 mg po bid Drug: vancomycin 1g iv bid
2: Active Comparator 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:

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.
Surgical debridement of infection site, as needed.
Subject is capable of providing written informed consent.
Subject is at least 18 years of age.
Subject capable of receiving outpatient parenteral therapy for 12 weeks.

Exclusion Criteria:

Hypersensitivity to TMP-SMX or vancomycin.
S. aureus resistant to TMP-SMX or vancomycin.
Osteomyelitis that develops directly from a chronic, open wound.
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).
Subject has a positive pregnancy test at study enrollment.
Convicted felon currently in prison.
Baseline renal or hepatic insufficiency that would preclude administration of study drugs.
Active injection drug use without safe conditions to administer intravenous antibiotics for 3 months.
Anticipated use of antibiotics for greater than 14 days for an infection other than osteomyelitis.

Contacts and Locations

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

Keywords provided by University of Washington:

Vancomycin
Trimethoprim-Sulfamethoxazole Combination

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Trimethoprim
Molecular Mechanisms of Pharmacological Action
Sulfamethoxazole
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Trimethoprim-Sulfamethoxazole Combination
Folic Acid Antagonists
Renal Agents
Infection

Bone Diseases
Pharmacologic Actions
Bone Diseases, Infectious
Anti-Bacterial Agents
Antimalarials
Staphylococcal Infections
Antiparasitic Agents
Gram-Positive Bacterial Infections
Musculoskeletal Diseases
Therapeutic Uses
Vancomycin
Osteomyelitis

ClinicalTrials.gov processed this record on November 27, 2009