DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)
NCT ID: NCT04682990
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2021-01-05
2021-12-05
Brief Summary
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World Health Organization (WHO) encourages the introduction of rapid, non-invasive and cheaper screening tests. In this scope, this study proposes the collection of exhaled breath samples and their analysis through the electronic nose made in Tor Vergata University (TV eNose) to diagnose TB and TB-HIV on their participants.
Detailed Description
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The enrolment phase of the participants will take 12 months. After this period, additional 6 months will be dedicated to the data analysis and dissemination of results.
Each patient meeting the inclusion criteria will be asked to join the study. Detailed information will be provided him/her. In case of acceptance the participants will undergo further sampling: breath test measurement. All data will be collected ensuring anonymity and privacy. Standard protocols used in the center will not be changed by the research, but each patient will be asked to provide 1 additional sample (exhaled breath in the bag sampler). Each study participant will be properly informed, and a consent form will be signed.
Preparation to participate: It will be required to patients to avoid drinking, eating, smoking, or brushing their teeth 2 hours before the breath test.
Sampling collection: In order to collect breath samples, two bags will be used, one for collecting airways breath (about 0.5 liter volume) and one for alveolar exhaled air (3 liters). It is asked to the patient after putting a clip nose, to inspire with the mouth and to deeply breath inside the bags through an antibacterial filter connected to the sampling apparatus.
At the end, the second bag (volume of 3 liters) contains the alveolar portion of breath that will be analyzed by the TV eNose. During the measurement, the TV eNose will be connected to the computer, to read and store the Volatile Organic Compounds (VOCs) pattern from breath given by the sensor array.
Other data are collected: clinical symptoms, TB LAMP results, and results of others test if available: chest X-ray, smear microscopic, sputum culture and GeneXpert MTB/RIF Assay examinations.
All personal data and results of the patients will be collected in a specific sheet elaborated by the partners (University di Roma Tor Vergata). It will be an Excel database and it will be store in the study site. All data collected will be anonymous.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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Pulmonary TB
This arm will enroll 80-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with pulmonary TB proved by TB LAMP test.
Interventions:
1. They will be asked to perform a breath exhalation with a nose clamp.
2. Medical History: Symptom based Survey, Physical Exam,and HIV status.
Other interventions:
* Sputum samples for Ziehl Neelsen smear or Culture in L-J or GeneXpert MTB/RIF;
* Chest X-ray Follow Up 5 days after beginning of Tx Follow Up 15 days after beginning of Tx Follow Up 30 days after beginning of Tx
Tor Vergata Electronic Nose (TV eNose)
Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose
Survey & Physical Exam
Perform a oriented survey for risk factors, symptoms and a complete physical exam.
TB LAMP test
Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)
Sputum Samples
Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)
Chest X-Ray
Perform anteroposterior chest X-ray (if required by the medical staff)
Follow Up 5 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come 5 days after initiation of treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 15 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 30 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Non Pulmonary TB
This arm will enroll 50-100 patients older than 18 years old, from the Center of Respiratory Diseases in Douala, with Negative pulmonary TB status proved by TB LAMP test. These Negative TB patients can be healthy controls or TB suspects.
Interventions:
They will be asked to perform a breath exhalation with a nose clamp. Medical History: Symptom based Survey, and HIV status.
Other interventions:
* Sputum samples for Ziehl Neelsen smear or Culture in L-J GeneXpert MTB/RIF;
* Chest X-ray.
Tor Vergata Electronic Nose (TV eNose)
Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose
Survey & Physical Exam
Perform a oriented survey for risk factors, symptoms and a complete physical exam.
TB LAMP test
Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)
Sputum Samples
Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)
Chest X-Ray
Perform anteroposterior chest X-ray (if required by the medical staff)
Interventions
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Tor Vergata Electronic Nose (TV eNose)
Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose
Survey & Physical Exam
Perform a oriented survey for risk factors, symptoms and a complete physical exam.
TB LAMP test
Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)
Sputum Samples
Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)
Chest X-Ray
Perform anteroposterior chest X-ray (if required by the medical staff)
Follow Up 5 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come 5 days after initiation of treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 15 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Follow Up & 30 days after beginning of Tx.
Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment.
Eligibility Criteria
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Inclusion Criteria
* Suspected of having TB on clinical base (4SS + or other clinical suggestions) with HIV+/- status
* Healthy control patient
* Able to produce exhaled air samples
* Able to produce sputum samples for TB LAMP test
Exclusion Criteria
* By discretion of the research team.
18 Years
ALL
Yes
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Yolande Christelle Ketchanji Mougang
Principal Investigator
Principal Investigators
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Leonardo Palombi, Professor
Role: STUDY_DIRECTOR
University of Rome Tor Vergata
Locations
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Centre des Maladies Respiratoire
Douala, Littoral Region, Cameroon
Countries
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Other Identifiers
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TB Project eNose-Cameroon
Identifier Type: -
Identifier Source: org_study_id