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Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects

Sponsor
Cepheid (Industry)
Overall Status
Completed
CT.gov ID
NCT01587469
Collaborator
AIDS Clinical Trials Group (Other), Centers for Disease Control and Prevention (U.S. Fed)
992
Enrollment
1
Location
21.7
Actual Duration (Months)
45.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will be compared to gold standard conventional culture methods on two sputum specimens, in HIV-infected and HIV-uninfected participants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    992 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects
    Actual Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Feb 21, 2014
    Actual Study Completion Date :
    Feb 21, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    HIV-infected and -uninfected individuals

    HIV-infected and -uninfected individuals with suspected TB infection

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear positive and MGIT culture positive for M.tuberculosis. [Week 0]

    2. Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear negative and MGIT culture positive for M.tuberculosis. [Week 0]

    3. Proportion of US participants with Xpert MTB/RIF Assay MTB negative in sputum #1 who are MGIT culture negative for M.tuberculosis. [Week 0]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Suspected pulmonary TB (more information on the criterion can be found in the protocol)

    • Men and women age equal to or greater than 18 years

    • Ability and willingness of candidate or legal guardian/representative to provide informed consent

    • Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry.

    • Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry.

    • Determination and/or documentation of HIV status

    • For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent.

    Exclusion Criteria:

    • Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing

    • Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection

    • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ucsf Aids Ctu San Francisco California United States 94110

    Sponsors and Collaborators

    • Cepheid
    • AIDS Clinical Trials Group
    • Centers for Disease Control and Prevention

    Investigators

    • Study Chair: Annie Luetkemeyer, MD, San Francisco General Hospital
    • Study Chair: Cynthia Firnhaber, MD, University of Witwatersrand, South Africa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cepheid
    ClinicalTrials.gov Identifier:
    NCT01587469
    Other Study ID Numbers:
    • ACTG A5295
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Tuberculosis
    Tuberculosis, Pulmonary

    Study Results

    No Results Posted as of Feb 6, 2018