Performance Evaluation of TB Breath- and Cough-testing Platforms

• Conditions: Pulmonary TB; Diagnoses Diseases
• Interventions: Device: Rapid Biosensor Systems (RBS) TB Breathalyser; Device: eNose AeonoseTM

• Registration Number: NCT03025516
• Lead Sponsor: Find

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-19
• Study Start: 2017-05-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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:

  1. Persistent cough
  2. Fever
  3. Malaise
  4. Recent weight loss
  5. Night sweats
  6. Contact w/ active case
  7. Hemoptysis
  8. Chest pain
  9. Loss of appetite
  10. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with pulmonary TB symptoms	eNose AeonoseTM	All patients will be tested with both the reference and index TB diagnostic tests. Index test results will not be used to inform case management. All samples must be collected before the patient starts any form of TB treatment. Patients will be randomized to receive either the TB Breathalyser or AeonoseTM on Day 1, and will be tested with the remaining breath-test on Day 2. A follow-up evaluation will be required after 8 weeks for all patients who do not have microbiologic confirmation of TB (smear or culture). Two additional breath samples may also be collected upon follow-up.
Adults with pulmonary TB symptoms	Rapid Biosensor Systems (RBS) TB Breathalyser	All patients will be tested with both the reference and index TB diagnostic tests. Index test results will not be used to inform case management. All samples must be collected before the patient starts any form of TB treatment. Patients will be randomized to receive either the TB Breathalyser or AeonoseTM on Day 1, and will be tested with the remaining breath-test on Day 2. A follow-up evaluation will be required after 8 weeks for all patients who do not have microbiologic confirmation of TB (smear or culture). Two additional breath samples may also be collected upon follow-up.

Primary Outcome Measures

Name	Time	Method
Microbiological TB Diagnosis	8 weeks	TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample

Trial Locations

Locations (1)

Nolungile Clinic, University of Cape Town; 🇿🇦 Cape Town, South Africa