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| Name | Class |
|---|---|
| The eNose Company | INDUSTRY |
| Foundation for Research in Mycobacteria (FUNDAIM) | OTHER |
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Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary TB | Experimental | This arm will enroll 100 patients older than 15 years old, from Caracas, with pulmonary TB, culture proved. Intervention:
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| Non - Pulmonary TB | Active Comparator | This arm will enroll 75 patients older than 15 years old, from Caracas, with non TB pulmonary infections, culture negative. Intervention:
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| Healthy Individuals | Active Comparator | This arm will enroll 75 patients older than 15 years old, from Caracas, without any symptom or sign of lower track infection. Intervention:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Nose | Device | 1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Effects related to the used of the device, assess by the CTCAE | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacobus De Waard, PhD | Instituto de Biomedicina de la Universidad Central de Venezuela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Biomedicina | Caracas | DC | 1040 | Venezuela |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 6, 2020 | |
| Reset | Jan 16, 2020 |
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| Survey & Physical Exam | Other | 2. Perform a oriented survey for risk factors and a complete physical exam. |
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| Chest X-ray | Other | Perform anteroposterior chest X-ray |
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| Sputum Samples | Other | Sputum samples for Ziehl Neelsen smear and Culture in L-J. |
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| Follow Up 5 days after beginning of Tx. | Device | 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. |
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| Follow Up 15 days after beginning of Tx. | Device | 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. |
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| Follow Up 30 days after beginning of Tx. | Device | 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. |
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| Follow Up 60 days after beginning of Tx. | Device | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 6, 2020 | Jan 16, 2020 |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D062609 | Electronic Nose |
| D011795 | Surveys and Questionnaires |
| D012149 | Restraint, Physical |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D055615 | Electrical Equipment and Supplies |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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