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

NCT01587469 | Completed

• 1 other identifier: ACTG A5295
• Study Type: observational
• Target: 992
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Proportion of US participants with Xpert MTB/RIF Assay MTB negative in sputum #1 who are MGIT culture negative for M.tuberculosis.

  Week 0

Study Arms (1)

HIV-infected and -uninfected individuals

HIV-infected and -uninfected individuals with suspected TB infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cepheid: lead
• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Ucsf Aids Ctu

San Francisco, California, 94110, United States

Location

Related Publications (1)

• Luetkemeyer AF, Firnhaber C, Kendall MA, Wu X, Mazurek GH, Benator DA, Arduino R, Fernandez M, Guy E, Johnson P, Metchock B, Sattler F, Telzak E, Wang YF, Weiner M, Swindells S, Sanne IM, Havlir DV, Grinsztejn B, Alland D; AIDS Clinical Trials Group A5295 and Tuberculosis Trials Consortium Study 34 Teams. Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients With Suspected Tuberculosis From Low and Higher Prevalence Settings. Clin Infect Dis. 2016 May 1;62(9):1081-8. doi: 10.1093/cid/ciw035. Epub 2016 Feb 2.

  PMID: 26839383 RESULT

Biospecimen

Retention: NONE RETAINED

Samples of sputum may be retained

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Annie Luetkemeyer, MD

  San Francisco General Hospital

  STUDY CHAIR

• Cynthia Firnhaber, MD

  University of Witwatersrand, South Africa

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 30, 2012
• Study Start: May 1, 2012
• Primary Completion: February 21, 2014
• Study Completion: February 21, 2014
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

US (1)