Clinical trial NCT02768909: Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
Official title: Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis, Pulmonary
e-Nose
Lead sponsor: Universidad Central de Venezuela
Sponsor class: OTHER
Collaborators: name: The ENose Company, Zutphen, Netherlands
name: Foundation for Research in Mycobacteria (FUNDAIM)
First posted: 2016-05-11
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
timeFrame: 1 year
measure: Average Days needed to observed a negative result with the device after initiation of treatment.
timeFrame: 60 days
Secondary outcomes:
measure: Number of Adverse Effects related to the used of the device, assess by the CTCAE
timeFrame: 1 year
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Instituto de Biomedicina
state: DC
Study officials:
affiliation: Instituto de Biomedicina de la Universidad Central de Venezuela
name: Jacobus De Waard, PhD
role: PRINCIPAL_INVESTIGATOR
References: