Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicill... | NCT00324922

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

NCT00324922

Sponsor

University of Washington

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

2Actual

Phase

Phase 3

Conditions

Osteomyelitis
Methicillin-resistant Staphylococcus Aureus

Interventions

trimethoprim-sulfamethoxazole
vancomycin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2006Actual

Primary Completion Date

May 1, 2007Actual

Completion Date

May 1, 2007Actual

First Submitted Date

May 9, 2006

First Submission Date that Met QC Criteria

May 9, 2006

First Posted Date

May 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2023

Last Update Posted Date

Apr 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trimethoprim-sulfamethoxazole	Active Comparator	trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks	Drug: trimethoprim-sulfamethoxazole Drug: vancomycin
Vancomycin	Active Comparator	Vancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks	Drug: vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trimethoprim-sulfamethoxazole	Drug	trimethoprim/sulfamethoxazole 320/1600 mg po bid	Trimethoprim-sulfamethoxazole

Measure	Description	Time Frame
Clinical cure	No clinical or radiographic evidence of infection at 12 months	12 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98104	United States

ID	Term
D010019	Osteomyelitis

ID	Term
D001850	Bone Diseases, Infectious
D007239	Infections
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D015662	Trimethoprim, Sulfamethoxazole Drug Combination
D014640	Vancomycin

Ancestor Terms

ID	Term
D013420	Sulfamethoxazole
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides

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Browse Branches

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