NCT00304811

Brief Summary

The purpose of this study is to compare the outcome of treatment for bacteremic MRSA infection with vancomycin alone, vancomycin plus gentamicin, vancomycin plus rifampin, and vancomycin plus gentamicin and rifampin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

March 16, 2006

Last Update Submit

September 25, 2009

Conditions

Staphylococcus Aureus

Keywords

MRSAMethicillin Resistant Staphylococcus aureus

Outcome Measures

Primary Outcomes (4)

  • Time to defervescence (24 hours of temperature <100 degrees F)

  • Return of WBC to normal (<10,500)

  • negative blood cultures

  • discharge

Interventions

VancomycinDRUG
Vancomycin plus GentamicinDRUG
Vancomycin plus RifampinDRUG
Vancomycin plus Gentamicin plus RifampinDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with MRSA in a blood culture processed as standard of care at the VAMC
  • Patients or next of kin willing to sign consent to be randomized by social security number to one of the treatments.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

VancomycinGentamicinsRifampin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsAminoglycosidesGlycosidesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Daniel M Musher, MD

    Baylor College of Medicine, Houston VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 20, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

US(2)