Clinical trial NCT03072576: Accuracy and Feasibility of Xpert Ultra
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Keywords: Diagnosis
Xpert MTB/RIF
Ultra Xpert MTB/RIF
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have symptoms consistent with pulmonary TB presenting to participating centres.

Two groups of participants will be recruited, namely a 'Case Detection Group' and a 'Drug-Resistant TB Group'.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF
timeFrame: Day 1
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Research and Practical Centre for Pulmonology and Tuberculosis
city: Tbilisi
country: Georgia
facility: Clinical Research Unit, National Center for Tuberculosis and Lung Diseases
city: Madras
country: India
facility: National Institute for Research in Tuberculosis
city: Mumbai
country: India
facility: Dept of Microbiology, Hinduja Hospital
city: New Delhi
country: India
facility: New Delhi Tuberculosis Centre
city: Johannesburg
country: South Africa
facility: 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
Study officials:
affiliation: Find
name: Claudia M Denkinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: