DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)

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.

Conditions

• Tuberculosis, Pulmonary
• HIV Seropositivity

Interventions

DEVICE

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

OTHER

Survey & Physical Exam

Perform a oriented survey for risk factors, symptoms and a complete physical exam.

DIAGNOSTIC_TEST

TB LAMP test

Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)

OTHER

Sputum Samples

Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)

OTHER

Chest X-Ray

Perform anteroposterior chest X-ray (if required by the medical staff)

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• University of Rome Tor Vergata

  lead OTHER

Principal Investigators

• Leonardo Palombi, Professor · University of Rome Tor Vergata

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-05

Primary Completion

2021-12-05

Completion

2021-12-05

Countries

• Cameroon

Study Locations