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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587469
• Other study ID #: ACTG A5295
• Status: Completed
• Phase: N/A
• First received: April 24, 2012
• Last updated: February 2, 2018
• Start date: May 2012
• Est. completion date: February 21, 2014

Study information

• Verified date: February 2018
• Source: Cepheid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: February 21, 2014
• Est. primary completion date: February 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
United States	Ucsf Aids Ctu	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Cepheid	AIDS Clinical Trials Group, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Proportion of US participants with Xpert MTB/RIF Assay MTB negative in sputum #1 who are MGIT culture negative for M.tuberculosis.		Week 0