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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT02768909 |
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Date of registration:
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11/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
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Scientific title:
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Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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250 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02768909 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Jacobus De Waard, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Biomedicina de la Universidad Central de Venezuela |
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Key inclusion & exclusion criteria
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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.
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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e-Nose
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Tuberculosis, Pulmonary
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Intervention(s)
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Device: Follow Up 5 days after beginning of Tx.
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Device: E-Nose
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Device: Follow Up 60 days after beginning of Tx.
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Device: Follow Up 15 days after beginning of Tx.
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Device: Follow Up 30 days after beginning of Tx.
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Other: Sputum Samples
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Other: Chest X-ray
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Other: Survey & Physical Exam
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Primary Outcome(s)
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Average Days needed to observed a negative result with the device after initiation of treatment.
[Time Frame: 60 days]
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Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Number of Adverse Effects related to the used of the device, assess by the CTCAE
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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