Pulmonary TBNCT03025516
Performance Evaluation of TB Breath- and Cough-testing Platforms
An observational study of Pulmonary TB and Diagnoses Diseases, run by Find at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary TB, Diagnoses Diseases
- What is being tested?
- Rapid Biosensor Systems (RBS) TB Breathalyser and eNose AeonoseTM
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 1 siteSouth Africa
- Study dates
- 29 May 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Nolungile Clinic, University of Cape Town
Cape Town, 7700
Shireen Surtie
Pamela Jordan
About this study
Official title: Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing
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
- Being tested
- Rapid Biosensor Systems (RBS) TB Breathalyser, eNose AeonoseTM
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Biosensor Systems (RBS) TB BreathalyserDevice
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 AeonoseTMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rapid Biosensor Systems (RBS) TB Breathalyser; Device: eNose AeonoseTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start29 May 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Find
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Timothy C Rodwell, MD, PhD, MPH, Study director, Find
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025516
- Sponsor's protocol ID
- P07212-00
- Status last verified
- Jul 2017
- First submitted
- 17 Jan 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing
- ClinicalTrials.gov ID
- NCT03025516
- Acronym / sponsor ID
- P07212-00
- Conditions
- Pulmonary TB, Diagnoses Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- FindUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, University of Cape Town
- Study start
- 29 May 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with pulmonary TB symptoms | – | Device: Rapid Biosensor Systems (RBS) TB Breathalyser, Device: eNose AeonoseTMAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
- 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)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Biosensor Systems (RBS) TB BreathalyserRapid 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 | Adults with pulmonary TB symptoms |
| eNose AeonoseTMThe 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. | Device | Adults with pulmonary TB symptoms |
Primary outcome
Microbiological TB Diagnosis
Time frame: 8 weeks
TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy C Rodwell, MD, PhD, MPH study director
Find
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary TB and Diagnoses Diseases, run by Find at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Arafah (+41 (22) 710 05 90, sonia.arafah@finddx.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological TB Diagnosis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.