DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

January 5, 2021

Primary Completion Date

December 5, 2021

Study Completion Date

December 5, 2021

Conditions
Tuberculosis, PulmonaryHIV 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."

Trial Locations (1)

Unknown

Centre des Maladies Respiratoire, Douala

All Listed Sponsors
lead

University of Rome Tor Vergata

OTHER

NCT04682990 - DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE) | Biotech Hunter | Biotech Hunter