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

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ClinicalTrials.gov Identifier: NCT01587469
Recruitment Status : Unknown
Verified April 2012 by Cepheid.
Recruitment status was:  Recruiting
First Posted : April 30, 2012
Last Update Posted : May 2, 2012
Information provided by (Responsible Party):

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

Study Design

Study Type : Observational
Estimated Enrollment : 1634 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
Study Start Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin
U.S. FDA Resources

Groups and Cohorts

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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Week 0 ]

Biospecimen Retention:   Samples With DNA
Samples of sputum may be retained

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1-infected and -uninfected men and women, 18 years and older, pulmonary TB suspects who have either a) smear positive sputum or b) clinical suspicion of pulmonary TB including one or more self-reported symptoms of cough, night sweats, weight loss, or fever. Within the 180 days prior to collection of the initial sputum sample, participants will have received none or fewer than 48 hours of TB treatment and, in those 48 hours, fewer than three doses of TB treatment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587469

United States, California
Ucsf Aids Ctu Recruiting
San Francisco, California, United States, 94110
Contact: Jay (John) Dwyer       jdwyer@php.ucsf.edu   
Principal Investigator: Diane Havlir, MD         
Sponsors and Collaborators
AIDS Clinical Trials Group
Centers for Disease Control and Prevention
Study Chair: Annie Luetkemeyer, MD San Francisco General Hospital
Study Chair: Cynthia Firnhaber, MD University of Witwatersrand, South Africa
More Information

Responsible Party: Cepheid
ClinicalTrials.gov Identifier: NCT01587469     History of Changes
Other Study ID Numbers: ACTG A5295
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers