Accuracy and Feasibility of Xpert Ultra

Foundation for Innovative New Diagnostics, Switzerland1,400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Tuberculosis, Pulmonary

Interventions

Xpert MTB/RIF UltraDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Case Detection Group 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) 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 Inclusion Criteria: * 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: • none

Locations (6)

Republican Research and Practical Centre for Pulmonology and Tuberculosis

Minsk, Belarus

Clinical Research Unit, National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

National Institute for Research in Tuberculosis

Madras, India

Dept of Microbiology, Hinduja Hospital

Mumbai, India

Outcomes

Primary Outcomes

Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint)

Time frame: Day 1

Secondary Outcomes

Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status

Time frame: Day 1

Sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra for detection of Rifampin (RIF) resistance

Time frame: Day 1

Difference in sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra and Xpert MTB/RIF for detection of RIF resistance

Time frame: Day 1

Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF

Time frame: Day 1

Data from ClinicalTrials.gov

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