Performance Evaluation of TB Breath- and Cough-testing Platforms

Pulmonary TB Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03025516
• Other study ID #: P07212-00
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2017
• Last updated: July 18, 2017
• Start date: May 29, 2017
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Find
• Contact: Sonia Arafah
• Phone: +41 (22) 710 05 90
• Email: sonia.arafah[@]finddx.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diagnoses Diseases
• Pulmonary TB
• Tuberculosis, Pulmonary

Intervention

Device:
• Rapid Biosensor Systems (RBS) TB Breathalyser
Rapid Biosensor Systems (RBS) recently developed a portable, non-invasive, rapid TB diagnostic 'Breathalyser' capable of diagnosing TB in patient breath samples collected while patients cough (Figure 1). The TB Breathalyser comprises a disposable, single-use sample collection tube and a multi-use reader. At the bottom of the collection tube is a glass bio-sensor coated with a biochemical sensor that is formulated to react with TB bacilli. Patients cough into the collection tube after nebulization with 0.9% saline solution. Following sample collection, the tube is placed into the reader, where a diode laser interrogates the biochemical coating in the sample collection tube and reports the presence of TB bacilli. The entire process takes about two minutes.
• eNose AeonoseTM
The eNose Company has also developed a hand-held, non-invasive rapid TB diagnostic 'electronic nose' (AeonoseTM) for TB detection based upon analysis of exhaled breath. After the device has been calibrated, the patient is instructed to breathe into the device through a mouthpiece for 5 minutes. Within the device is a micro-hotplate, metal-oxide sensor which behaves as a semiconductor at high temperature. Redox-reactions occurring at the sensor surface result in changes in resistance, with results read and interpreted by a phone application to confirm the presence of MTB.

Locations

Country	Name	City	State
South Africa	Nolungile Clinic, University of Cape Town	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
Find	Universidad Peruana Cayetano Heredia, University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological TB Diagnosis	TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample	8 weeks