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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02768909
Study type	Interventional
Source	Universidad Central de Venezuela
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 2015
Completion date	February 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.