Tuberculosis, PulmonaryNCT02768909
Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
A study testing E-Nose, Survey & Physical Exam and Chest X-ray in people with Tuberculosis, Pulmonary and e-Nose, run by Universidad Central de Venezuela at 1 site in Venezuela.
Trial summary
Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary, e-Nose
- What is being tested?
- E-Nose, Survey & Physical Exam and Chest X-ray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteVenezuela
- Study dates
- Jan 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
Read the 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.
- Conditions
- Tuberculosis, Pulmonary, e-Nose
- Being tested
- E-Nose, Survey & Physical Exam, Chest X-ray, Sputum Samples, Follow Up 5 days after beginning of Tx.
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-NoseDevice
1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
Survey & Physical ExamOther
- Perform a oriented survey for risk factors and a complete physical exam.
Chest X-rayOther
Perform anteroposterior chest X-ray
Sputum SamplesOther
Sputum samples for Ziehl Neelsen smear and Culture in L-J.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary TB | Experimental | This 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 Receives: Device: E-Nose; Other: Survey & Physical Exam; Other: Chest X-ray; Other: Sputum Samples; Device: Follow Up 5 days after beginning of Tx.; Device: Follow Up 15 days after beginning of Tx.; Device: Follow Up 30 days after beginning of Tx.; Device: Follow Up 60 days after beginning of Tx. |
| 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:
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. Receives: Device: E-Nose; Other: Survey & Physical Exam; Other: Chest X-ray; Other: Sputum Samples |
| 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:
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. Receives: Device: E-Nose; Other: Survey & Physical Exam; Other: Chest X-ray; Other: Sputum Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Average Days needed to observed a negative result with the device after initiation of treatment.
Days-to-negative.
Measured: 60 days
Secondary outcomes (1)
Number of Adverse Effects related to the used of the device, assess by the CTCAE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Central de Venezuela
- Sponsor type
- University, hospital or other
- Collaborators
- The eNose Company, Foundation for Research in Mycobacteria (FUNDAIM)
- Responsible party
- Principal investigator, Jacobus H. de Waard, Universidad Central de Venezuela
- Investigators
- Jacobus De Waard, PhD, Principal investigator, Instituto de Biomedicina de la Universidad Central de Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768909
- Sponsor's protocol ID
- EN001
- Status last verified
- May 2016
- First submitted
- 11 Apr 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
- ClinicalTrials.gov ID
- NCT02768909
- Acronym / sponsor ID
- EN001
- Conditions
- Tuberculosis, Pulmonary, e-Nose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universidad Central de VenezuelaUniversity, hospital or other
- Collaborators
- The eNose Company, Foundation for Research in Mycobacteria (FUNDAIM)
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary TB | Experimental | Device: E-Nose, Other: Survey & Physical Exam, Other: Chest X-ray, Other: Sputum Samples, Device: Follow Up 5 days after beginning of Tx., Device: Follow Up 15 days after beginning of Tx., Device: Follow Up 30 days after beginning of Tx., Device: Follow Up 60 days after beginning of Tx.This 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 comparator | Device: E-Nose, Other: Survey & Physical Exam, Other: Chest X-ray, Other: Sputum SamplesThis 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 comparator | Device: E-Nose, Other: Survey & Physical Exam, Other: Chest X-ray, Other: Sputum SamplesThis 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-Nose1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp. | Device | Healthy Individuals, Non - Pulmonary TB, Pulmonary TB |
| Survey & Physical Exam2. Perform a oriented survey for risk factors and a complete physical exam. | Other | Healthy Individuals, Non - Pulmonary TB, Pulmonary TB |
| Chest X-rayPerform anteroposterior chest X-ray | Other | Healthy Individuals, Non - Pulmonary TB, Pulmonary TB |
| Sputum SamplesSputum samples for Ziehl Neelsen smear and Culture in L-J. | Other | Healthy Individuals, Non - Pulmonary TB, Pulmonary TB |
| 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 | Pulmonary TB |
| 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 | Pulmonary TB |
| 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 | Pulmonary TB |
| 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. | Device | Pulmonary TB |
Primary outcome
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
Time frame: 1 year
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.
Average Days needed to observed a negative result with the device after initiation of treatment.
Time frame: 60 days
Days-to-negative.
1 secondary outcome
Number of Adverse Effects related to the used of the device, assess by the CTCAE
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobus De Waard, PhD principal investigator
Instituto de Biomedicina de la Universidad Central de Venezuela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Nose, Survey & Physical Exam and Chest X-ray in people with Tuberculosis, Pulmonary and e-Nose, run by Universidad Central de Venezuela at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.