NCT03072576

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

March 2, 2017

Last Update Submit

February 6, 2018

Conditions

Tuberculosis, Pulmonary

Keywords

DiagnosisXpert MTB/RIFUltra Xpert MTB/RIF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Interventions

Xpert MTB/RIF UltraDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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'.

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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)
  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Republican Research and Practical Centre for Pulmonology and Tuberculosis

Minsk, Belarus

Location

Clinical Research Unit, National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

Location

National Institute for Research in Tuberculosis

Madras, India

Location

Dept of Microbiology, Hinduja Hospital

Mumbai, India

Location

New Delhi Tuberculosis Centre

New Delhi, India

Location

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

Location

MeSH Terms

Conditions

Tuberculosis, PulmonaryDisease

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia M Denkinger, MD, PhD

    Find

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 7, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

IN(3)GE(1)ZA(1)BE(1)