NCT00324922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

May 9, 2006

Last Update Submit

April 7, 2023

Conditions

OsteomyelitisMethicillin-resistant Staphylococcus Aureus

Keywords

VancomycinTrimethoprim-Sulfamethoxazole Combination

Outcome Measures

Primary Outcomes (1)

  • Clinical cure

    No clinical or radiographic evidence of infection at 12 months

    12 months

Study Arms (2)

Trimethoprim-sulfamethoxazole

ACTIVE COMPARATOR

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

Drug: trimethoprim-sulfamethoxazoleDrug: vancomycin

Vancomycin

ACTIVE COMPARATOR

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

Drug: vancomycin

Interventions

trimethoprim-sulfamethoxazoleDRUG

trimethoprim/sulfamethoxazole 320/1600 mg po bid

Trimethoprim-sulfamethoxazole
vancomycinDRUG

1g iv bid

Trimethoprim-sulfamethoxazoleVancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

Trimethoprim, Sulfamethoxazole Drug CombinationVancomycin

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Allergy & Infectious Diseases, Medicine

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations

US(1)