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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

trimethoprim-sulfamethoxazole

vancomycin

About this trial

This is an interventional treatment trial for Osteomyelitis focused on measuring Vancomycin, Trimethoprim-Sulfamethoxazole Combination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Trimethoprim-sulfamethoxazole

Vancomycin

Arm Description

trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks

Vancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks

Outcomes

Primary Outcome Measures

Clinical cure

No clinical or radiographic evidence of infection at 12 months

Secondary Outcome Measures

Full Information

NCT ID

NCT00324922

First Posted

May 9, 2006

Last Updated

April 7, 2023

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT00324922

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2006 (Actual)

Primary Completion Date

May 1, 2007 (Actual)

Study Completion Date

May 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteomyelitis, Methicillin-resistant Staphylococcus Aureus

Keywords

Vancomycin, Trimethoprim-Sulfamethoxazole Combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trimethoprim-sulfamethoxazole

Arm Type

Active Comparator

Arm Description

trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks

Arm Title

Vancomycin

Arm Type

Active Comparator

Arm Description

Vancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks

Intervention Type

Drug

Intervention Name(s)

trimethoprim-sulfamethoxazole

Intervention Description

trimethoprim/sulfamethoxazole 320/1600 mg po bid

Intervention Type

Drug

Intervention Name(s)

vancomycin

Intervention Description

1g iv bid

Primary Outcome Measure Information:

Title

Clinical cure

Description

No clinical or radiographic evidence of infection at 12 months

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials: