Accuracy and Feasibility of Xpert Ultra

Completed

• Conditions: Tuberculosis, Pulmonary

• Registration Number: NCT03072576
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2017-03
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-07
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	Day 1

Secondary Outcome Measures

Name	Time	Method
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	Day 1
Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status	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	Day 1
Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF	Day 1

Trial Locations

Locations (6)

National Institute for Research in Tuberculosis; 🇮🇳 Madras, India

Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, University of the Witwatersrand, and The National Priority Program of the National Health Laboratory Service; 🇿🇦 Johannesburg, South Africa

Republican Research and Practical Centre for Pulmonology and Tuberculosis; 🇧🇾 Minsk, Belarus

Dept of Microbiology, Hinduja Hospital; 🇮🇳 Mumbai, India

New Delhi Tuberculosis Centre; 🇮🇳 New Delhi, India

Clinical Research Unit, National Center for Tuberculosis and Lung Diseases; 🇬🇪 Tbilisi, Georgia