Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
1 other identifier
interventional
250
1 country
1
Brief Summary
Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 11, 2016
May 1, 2016
1.9 years
April 11, 2016
May 9, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
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.
1 year
Average Days needed to observed a negative result with the device after initiation of treatment.
Days-to-negative.
60 days
Secondary Outcomes (1)
Number of Adverse Effects related to the used of the device, assess by the CTCAE
1 year
Study Arms (3)
Pulmonary TB
EXPERIMENTALThis 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
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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.
Interventions
1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
2\. Perform a oriented survey for risk factors and a complete physical exam.
Perform anteroposterior chest X-ray
Sputum samples for Ziehl Neelsen smear and Culture in L-J.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Biomedicina
Caracas, DC, 1040, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacobus De Waard, PhD
Instituto de Biomedicina de la Universidad Central de Venezuela
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Tuberculosis Laboratory
Study Record Dates
First Submitted
April 11, 2016
First Posted
May 11, 2016
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
May 11, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share