Performance Evaluation of TB Breath- and Cough-testing Platforms

NCT03025516 | Unknown

• 1 other identifier: P07212-00
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

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

Interventions

Rapid Biosensor Systems (RBS) TB Breathalyser 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.

Adults with pulmonary TB symptoms

eNose AeonoseTM 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.

Adults with pulmonary TB symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who have symptoms consistent with pulmonary TB presenting to health facilities during study period. Patients will be asked by study or non-study clinicians or staff if they would be interested in participating in the study. Interested individuals will be referred to study personnel for additional information and screening, if appropriate, samples will be obtained following the informed consent process.

You may qualify if:

• 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
• Fever
• Malaise
• Recent weight loss
• Night sweats
• Contact w/ active case
• Hemoptysis
• Chest pain
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Find: lead
• Universidad Peruana Cayetano Heredia: collaborator
• University of Cape Town: collaborator

Study Sites (1)

Nolungile Clinic, University of Cape Town

Cape Town, 7700, South Africa

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All consenting patients are expected to provide the following samples: 2x breath/cough samples, which will be collected directly into enclosed diagnostic devices and destroyed immediately following diagnosis; blood samples for HIV testing, which will be de-identified and stored until study completion; urine samples; and 3x sputum samples, collected at enrollment and during an 8-week follow-up, de-identified and used for liquid culture, solid culture, AFB smear, and DNA extraction for Xpert testing. Except for the breath samples, all samples will be de-identified and stored until study completion.

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Timothy C Rodwell, MD, PhD, MPH

  Find

  STUDY DIRECTOR

Central Study Contacts

Sonia Arafah

CONTACT

+41 (22) 710 05 90; sonia.arafah@finddx.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: May 29, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)