DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)

NCT04682990 | Completed

• 1 other identifier: TB Project eNose-Cameroon
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis, Pulmonary; HIV Seropositivity

Keywords

Tuberculosis; Breath test; Volatile Organic Compounds (VOCs)

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants

  Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose.The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.

  6 months

• Accuracy value of the diagnostic between Pulmonary TB, Pulmonary TB+ HIV patients and control patients with the TV eNose

  Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose. The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.

  6 months

Secondary Outcomes (1)

• Average Days needed to observed a negative result with the device after initiation of treatment.

  6 months

Study Arms (2)

Pulmonary TB

EXPERIMENTAL

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

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

Non Pulmonary TB

ACTIVE COMPARATOR

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.

Device: Tor Vergata Electronic Nose (TV eNose); Other: Survey & Physical Exam; Diagnostic Test: TB LAMP test; Other: Sputum Samples; Other: Chest X-Ray

Interventions

Tor Vergata Electronic Nose (TV eNose) DEVICE

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

Non Pulmonary TB; Pulmonary TB

Survey & Physical Exam OTHER

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

Non Pulmonary TB; Pulmonary TB

TB LAMP test DIAGNOSTIC_TEST

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

Non Pulmonary TB; Pulmonary TB

Sputum Samples OTHER

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

Non Pulmonary TB; Pulmonary TB

Chest X-Ray OTHER

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

Non Pulmonary TB; Pulmonary TB

Follow Up 5 days after beginning of Tx. OTHER

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.

Pulmonary TB

Follow Up & 15 days after beginning of Tx. OTHER

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.

Pulmonary TB

Follow Up & 30 days after beginning of Tx. OTHER

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.

Pulmonary TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Centre des Maladies Respiratoire

Douala, Littoral Region, Cameroon

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; HIV Seropositivity; Tuberculosis

Interventions

Surveys and Questionnaires; Restraint, Physical; X-Rays

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Leonardo Palombi, Professor

  University of Rome Tor Vergata

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Positive TB patients (Arm 1) and Negative TB patients (Arm 2 ). All the patients can be HIV positive or not .

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 24, 2020
• Study Start: January 5, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CA (1)