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Performance Evaluation of TB Breath- and Cough-testing Platforms

NCT03025516 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2017-07-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Find

    lead OTHER

Principal Investigators

  • Timothy C Rodwell, MD, PhD, MPH · Find

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03025516 on ClinicalTrials.gov