Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing

Find1 site in 1 country360 target enrollmentMay 29, 2017

ConditionsPulmonary TB Diagnoses Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary TB
Sponsor: Find
Enrollment: 360
Locations: 1
Primary Endpoint: Microbiological TB Diagnosis
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.

Registry

clinicaltrials.gov

Start Date

May 29, 2017

End Date

December 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Find

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptoms suggesting pulmonary TB, i.e. persistent cough (generally \> 3 weeks or as per local definition of TB suspect) and at least one other finding listed below:
•Persistent cough
•Recent weight loss
•Night sweats
•Contact w/ active case
•Loss of appetite
•Other \[specify\]
•Provision of informed consent to sample collection, banking and HIV and breath-based assay testing
•Production of adequate quantity of sputum (sputum induction whenever possible)
•Adult age (\>18 years old)

Exclusion Criteria

•Participants receiving any anti-tuberculosis medication, including fluoroquinolone and aminoglycosides in the 60 days prior to enrolment.
•Participants with ONLY extra-pulmonary disease will be excluded.
•Participants for whom complete follow-up and a clear final diagnosis are judged to be difficult (e.g. residents elsewhere or about to move).