Accuracy and Feasibility of Xpert Ultra (NCT03072576)

01

Study 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.

02

Conditions studied

Tuberculosis, Pulmonary

Browse trials for

Keywords

Diagnosis
Xpert MTB/RIF
Ultra Xpert MTB/RIF

03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 1,400 is above the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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'.

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

05

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,400 participants (actual)
Patient registry: No

Interventions

DeviceXpert 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
Also known as: Cepheid Ultra

06

What researchers measure

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

07

Study locations

6 sites

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
New Delhi Tuberculosis Centre
New Delhi, 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

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID: NCT03072576
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Responsible party: Sponsor
First posted: Mar 7, 2017
Start date: Mar 2016
Primary completion: Mar 2017
Completion: Oct 2017
Last update: Feb 8, 2018

Study contacts

Claudia M Denkinger, MD, PhD

principal investigator · Find

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Accuracy and Feasibility of Xpert Ultra