Clinical trial NCT00324922: Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis
Official title: A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteomyelitis
Methicillin-resistant Staphylococcus Aureus
Keywords: Vancomycin
Trimethoprim-Sulfamethoxazole Combination
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinical cure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: UW
name: Timothy H. Dellitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Jeanne Chan, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Matthew Golden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: M. Bradford Henley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Jeanne M Marrazzo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Lisa Taitsman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Thomas R Hawn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW
name: Robert D Harrington, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Christian Ramers, MD
role: PRINCIPAL_INVESTIGATOR
References: