CompletedNot Applicable

Accuracy and Feasibility of Xpert Ultra

Belarus, Georgia, India1,400 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: Day 1

Trial details

NCT IDNCT03072576

SponsorFoundation for Innovative New Diagnostics, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Tuberculosis, Pulmonary trials