Performance Evaluation of TB Breath- and Cough-testing Platforms

Find

Status: Unknown

Conditions: Pulmonary TB; Diagnoses Diseases

Treatments: Device: Rapid Biosensor Systems (RBS) TB Breathalyser; Device: eNose AeonoseTM

Study type: Observational

Funder types: Other

Identifiers

NCT03025516

P07212-00

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

360 participants in 1 patient group

Adults with pulmonary TB symptoms

Description:

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.

Treatment:

Device: eNose AeonoseTM

Device: Rapid Biosensor Systems (RBS) TB Breathalyser