DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)

University of Rome Tor Vergata

Status: Completed

Conditions: Tuberculosis, Pulmonary; HIV Seropositivity

Treatments: Other: Survey & Physical Exam; Diagnostic Test: TB LAMP test; Other: Follow Up & 15 days after beginning of Tx.; Other: Chest X-Ray; Device: Tor Vergata Electronic Nose (TV eNose); Other: Follow Up & 30 days after beginning of Tx.; Other: Follow Up 5 days after beginning of Tx.; Other: Sputum Samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04682990

TB Project eNose-Cameroon

Details and patient eligibility

About

Tuberculosis (TB) is one of the top 10 causes of death in the world. More than 95% of TB deaths are in middle- and middle-income countries. Low incomes and long-term diagnosis promote this persistence. In 2017, Cameroon was the 3rd in the top of 20 countries with the highest estimated numbers of incident TB cases among people living with HIV, based on the severity of their TB burden.

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.

Full description

It is a 12 -month dynamic, open, descriptive and analytical type case-control study in adults. The present study intends to recruit , all the Pulmonary TB suspects and case notified by TB Loop-mediated isothermal Amplification(LAMP), sputum culture or GeneXpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) Assay, Pulmonary TB+HIV patients, healthy control patients, HIV patients without TB. Each patient will undergo at least two tests: the Breath Test Measurement and the TB LAMP. The TB LAMP will be used like the reference test for positive TB cases.

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Accept to participate in the study through a signed informed consent approved by the Ethical Committee (CEI of Douala - Cameroon)
• 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

• Unable to breath normally for 2 minutes due to respiratory illness
• By discretion of the research team.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Pulmonary TB

Experimental group

Description:

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

Treatment:

Other: Chest X-Ray

Other: Survey & Physical Exam

Other: Follow Up & 15 days after beginning of Tx.

Device: Tor Vergata Electronic Nose (TV eNose)

Other: Follow Up & 30 days after beginning of Tx.

Other: Sputum Samples

Other: Follow Up 5 days after beginning of Tx.

Diagnostic Test: TB LAMP test

Non Pulmonary TB

Active Comparator group

Description:

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.

Treatment:

Other: Chest X-Ray

Other: Survey & Physical Exam

Device: Tor Vergata Electronic Nose (TV eNose)

Other: Sputum Samples

Diagnostic Test: TB LAMP test