Performance Evaluation of TB Breath- and Cough-testing Platforms

NCT ID: NCT03025516

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2017-12-31

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.

Conditions

Pulmonary TB; Diagnoses Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with pulmonary TB symptoms

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.

Rapid Biosensor Systems (RBS) TB Breathalyser

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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:

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

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OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy C Rodwell, MD, PhD, MPH

Role: STUDY_DIRECTOR

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Locations

Nolungile Clinic, University of Cape Town

Cape Town, , South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Sonia Arafah

Role: CONTACT

sonia.arafah@finddx.org

+41 (22) 710 05 90

Facility Contacts

Shireen Surtie

Role: primary

Pamela Jordan

Role: backup

Other Identifiers

P07212-00

Identifier Type: -

Identifier Source: org_study_id