NCT01198262

Brief Summary

The purpose of this study is to determine whether the Cepheid GeneXpert system accurately detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and wound swabs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

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

April 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
Last Updated

September 10, 2010

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

September 9, 2010

Last Update Submit

September 9, 2010

Conditions

Staphylococcus AureusStaphylococcal Skin InfectionsBacteremia

Keywords

polymerase chain reaction

Outcome Measures

Primary Outcomes (1)

  • concordance between PCR results and those of standard bacteriologic culture

    1 year

Secondary Outcomes (1)

  • Impact of early identification of S. aureus on the antibiotics prescribed by physicians and subsequent clinical outcome.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population includes adult and geriatric patients at the Michael E. DeBakey VA Medical Center for have suspected blood and wound infections.

You may qualify if:

  • Positive blood culture with Gram stain revealing Gram positive cocci in clusters
  • All wound swabs submitted to the microbiology lab for standard bacteriologic culture may be included.

You may not qualify if:

  • Blood cultures that became positive more than 24 hours previously
  • Wound swabs for which over 48 hours have passed from the time of collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Staphylococcal InfectionsStaphylococcal Skin InfectionsBacteremia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel M Musher, MD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Mark Parta, MD

    Michael E. DeBakey VA Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

April 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

September 10, 2010

Record last verified: 2008-10

Locations

US(1)