Accuracy and Feasibility of Xpert Ultra

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-10-31

Brief Summary

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Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis will be interviewed for demographic and medical information, and then will be asked to provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis and rifampin resistance.

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Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Xpert MTB/RIF Ultra

Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin

Intervention Type DEVICE

Other Intervention Names

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Cepheid Ultra

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or above;
* Provision of informed consent;
* Willingness to provide 4 sputum specimens at enrolment;
* Willingness to have a study follow-up visit approximately 42 to 70 days after enrolment
* Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB)

* Age 18 years or above;
* Provision of informed consent;
* Willingness to provide 4 sputum specimens at enrolment;
* Non-converting pulmonary TB cases (category I and category II failures) or multi-drug resistant (MDR) suspect\* (based on World Health Organization definition), i.e. at least one of the following: i) retreatment cases, ii) active TB cases that are MDR-contacts and iii) patients at high risk for MDR-TB as determined by local program (e.g. prisoners)

Exclusion Criteria

* Receipt of any dose of TB treatment within 6 months prior to enrolment
* Participants for whom, at the time of enrolment, the follow-up visit is judged to be poorly feasible (e.g. individuals planning to relocate)

Drug-Resistant TB Group

• none

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No