Accuracy and Feasibility of Xpert Ultra

Tuberculosis, Pulmonary Clinical Trial

Official title:

A Multicentre Study of the Diagnostic Accuracy and Feasibility of the Xpert Ultra for Detection of TB and Rifampin Resistance in Adults Suspected of Having Pulmonary TB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072576
• Other study ID #: 7210-04-2/1
• Status: Completed
• Phase: N/A
• First received: March 2, 2017
• Last updated: February 6, 2018
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: October 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belarus	Republican Research and Practical Centre for Pulmonology and Tuberculosis	Minsk
Georgia	Clinical Research Unit, National Center for Tuberculosis and Lung Diseases	Tbilisi
India	National Institute for Research in Tuberculosis	Madras
India	Dept of Microbiology, Hinduja Hospital	Mumbai
India	New Delhi Tuberculosis Centre	New Delhi
South Africa	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

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Countries where clinical trial is conducted

Belarus,  Georgia,  India,  South Africa, 

Outcome

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