Accuracy and Feasibility of Xpert Ultra

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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Device: Xpert MTB/RIF Ultra

• Study Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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'.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF	Day 1

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Investigators: Principal Investigator: Claudia M Denkinger, MD, PhD, Find

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Diagnosis; Xpert MTB/RIF; Ultra Xpert MTB/RIF
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: 7210-04-2/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No