Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis

Osteomyelitis Clinical Trial

Official title:

A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324922
• Other study ID #: 27915
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2006
• Est. completion date: May 1, 2007

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 1, 2007
• Est. primary completion date: May 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Osteomyelitis
• Staphylococcal Infections

Intervention

Drug:
• trimethoprim-sulfamethoxazole
trimethoprim/sulfamethoxazole 320/1600 mg po bid
• vancomycin
1g iv bid

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure	No clinical or radiographic evidence of infection at 12 months	12 months