Clinical trial NCT04682990: DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)
Official title: DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH TEST Center: Douala - CAMEROON
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis, Pulmonary
HIV Seropositivity
Keywords: Tuberculosis
Breath test
Volatile Organic Compounds (VOCs)
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Positive TB patients (Arm 1) and Negative TB patients (Arm 2 ). All the patients can be HIV positive or not .
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants
timeFrame: 6 months
measure: Accuracy value of the diagnostic between Pulmonary TB, Pulmonary TB+ HIV patients and control patients with the TV eNose
timeFrame: 6 months
Secondary outcomes:
measure: Average Days needed to observed a negative result with the device after initiation of treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Centre des Maladies Respiratoire
state: Littoral
Study officials:
affiliation: University of Rome Tor Vergata
name: Leonardo Palombi, Professor
role: STUDY_DIRECTOR
References: