Overview

This trial is active, not recruiting.

Conditions tuberculosis, pulmonary, e-nose
Treatments e-nose, survey & physical exam, chest x-ray, sputum samples, follow up 5 days after beginning of tx., follow up 15 days after beginning of tx., follow up 30 days after beginning of tx., follow up 60 days after beginning of tx.
Sponsor Universidad Central de Venezuela
Collaborator The ENose Company, Zutphen, Netherlands
Start date January 2015
End date December 2016
Trial size 250 participants
Trial identifier NCT02768909, EN001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention: They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. Chest X-ray. Sputum samples for Ziehl Neelsen smear and Culture in L-J. Follow Up 5 days after beginning of Tx Follow Up 15 days after beginning of Tx Follow Up 30 days after beginning of Tx Follow Up 60 days after beginning of Tx
e-nose
1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
survey & physical exam
2. Perform a oriented survey for risk factors and a complete physical exam.
chest x-ray
Perform anteroposterior chest X-ray
sputum samples
Sputum samples for Ziehl Neelsen smear and Culture in L-J.
follow up 5 days after beginning of tx.
Patients 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, Anthropometric measurement, to determine progress of treatment.
follow up 15 days after beginning of tx.
Patients will be asked to come 15 days after initiation of treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment.
follow up 30 days after beginning of tx.
Patients will be asked to come 30 days after initiation of treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment.
follow up 60 days after beginning of tx.
Patients will be asked to come 60 days after initiation of treatment, to perform another measurement with the device. Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment.
(Active Comparator)
This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention: They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. Chest X-ray. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
e-nose
1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
survey & physical exam
2. Perform a oriented survey for risk factors and a complete physical exam.
chest x-ray
Perform anteroposterior chest X-ray
sputum samples
Sputum samples for Ziehl Neelsen smear and Culture in L-J.
(Active Comparator)
This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention: They will be asked to perform a respiration for 5 minutes through the E-Nose Device, with a nose clamp. Medical History: Symptom based Survey, Physical Exam, Anthropometric measurement. Chest X-ray. Sputum samples for Ziehl Neelsen smear and Culture in L-J.
e-nose
1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
survey & physical exam
2. Perform a oriented survey for risk factors and a complete physical exam.
chest x-ray
Perform anteroposterior chest X-ray
sputum samples
Sputum samples for Ziehl Neelsen smear and Culture in L-J.

Primary Outcomes

Measure
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
time frame: 1 year
Average Days needed to observed a negative result with the device after initiation of treatment.
time frame: 60 days

Secondary Outcomes

Measure
Number of Adverse Effects related to the used of the device, assess by the CTCAE
time frame: 1 year

Eligibility Criteria

Male or female participants at least 15 years old.

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.

Additional Information

Official title Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
Principal investigator Jacobus De Waard, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidad Central de Venezuela.