Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB

Not Applicable

• Conditions: Tuberculosis, Pulmonary; e-Nose
• Interventions: Device: E-Nose; Other: Survey & Physical Exam; Other: Chest X-ray; Other: Sputum Samples; Device: Follow Up 5 days after beginning of Tx.; Device: Follow Up 15 days after beginning of Tx.; Device: Follow Up 30 days after beginning of Tx.; Device: Follow Up 60 days after beginning of Tx.

• Registration Number: NCT02768909
• Lead Sponsor: Universidad Central de Venezuela

Brief Summary

Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.

Detailed Description

Acronyms:

Tuberculosis (TB) Receiver Operating Curve (ROC) Common Terminology Criteria for Adverse Effects (CTCAE)

The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose' for Pulmonary Tuberculosis. Prospective, Open, Three - Arm Controlled trial Study. Validation of the E-nose in urban settings to estimate the diagnostic accuracy of the E-nose using exhaled air in patients with Pulmonary TB in adults.

The patients who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in Netherlands.

During and after the use of the device, we determine the adverse effects of the intervention, according to the CTCEA.

The researchers use the sputum culture, which is the gold standard, to determine the diagnostic utility of the test. And, will compare the results with other tests currently perform as the regular diagnostic routine, such as Chest X-ray, sputum smear, and symptom based diagnosis.

The patients in the experimental group are invited to come during the treatment phase, and will be asses the progress of the treatment, as well as another use of the device, at 5, 15, 30, 60 days after initiation of treatment, and will be compared the results of the device, with symptoms, x-ray changes, improvement of anthropometric findings, to determine the utility of the device to measure the response to treatment.

Patient Registries will be keep in an electronic database, as well as handwriting history, with the backup copy in the records of the hospital in which the patient was admitted.

auditoriae will be realised by the Ethics Comite in different time frames.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-04-11
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-11
• Last Update Posted: 2016-05-11
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
• More than 15 years old.
• People with a culture positive for pulmonary TB

Exclusion Criteria

• Severe compromise of the general condition.
• Not capable to exhaled through the E-nose.
• No possibility to follow-up.
• By discretion of the research team.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary TB	Chest X-ray	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Pulmonary TB	Follow Up 5 days after beginning of Tx.	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Pulmonary TB	E-Nose	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Pulmonary TB	Sputum Samples	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Pulmonary TB	Follow Up 60 days after beginning of Tx.	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Pulmonary TB	Survey & Physical Exam	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Non - Pulmonary TB	E-Nose	This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Non - Pulmonary TB	Chest X-ray	This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Non - Pulmonary TB	Sputum Samples	This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Healthy Individuals	Survey & Physical Exam	This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Pulmonary TB	Follow Up 30 days after beginning of Tx.	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Non - Pulmonary TB	Survey & Physical Exam	This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Healthy Individuals	E-Nose	This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Healthy Individuals	Chest X-ray	This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
Pulmonary TB	Follow Up 15 days after beginning of Tx.	This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J. 5. Follow Up 5 days after beginning of Tx 6. Follow Up 15 days after beginning of Tx 7. Follow Up 30 days after beginning of Tx 8. Follow Up 60 days after beginning of Tx
Healthy Individuals	Sputum Samples	This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention: 1. They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. 2. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. 3. Chest X-ray. 4. Sputum samples for Ziehl Neelsen smear and Culture in L-J.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.	1 year	Sensitivity, Specificity and Predictive Values; calculated with an ROC curve based on the Average processed-signal of the three electronic nose sensors. The signal is generated with a complex pattern recognition software, measuring the adsorption rate, desorption rate, and area under the curve generated by each sensor, expressed with a single value that ranges between -1 to +1.
Average Days needed to observed a negative result with the device after initiation of treatment.	60 days	Days-to-negative.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Effects related to the used of the device, assess by the CTCAE	1 year

Trial Locations

Locations (1)

Instituto de Biomedicina; 🇻🇪 Caracas, DC, Venezuela