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

Summary

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

Conditions

• Tuberculosis, Pulmonary
• e-Nose

Interventions

DEVICE

E-Nose

1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.

OTHER

Survey & Physical Exam

2\. Perform a oriented survey for risk factors and a complete physical exam.

OTHER

Chest X-ray

Perform anteroposterior chest X-ray

OTHER

Sputum Samples

Sputum samples for Ziehl Neelsen smear and Culture in L-J.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• The ENose Company, Zutphen, Netherlands

  collaborator UNKNOWN

• Foundation for Research in Mycobacteria (FUNDAIM)

  collaborator OTHER

• Universidad Central de Venezuela

  lead OTHER

Principal Investigators

• Jacobus De Waard, PhD · Instituto de Biomedicina de la Universidad Central de Venezuela

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2016-12-31

Completion

2017-02-28

Countries

• Venezuela

Study Locations