TuberculosisNCT01748357
Siemens VOC TB Pilot Study
An observational study of Tuberculosis, run by Research Center Borstel at 1 site in Germany.
Trial summary
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: See groups described above
Who may be able to join
- Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or healthy subject that is not employed or working at the study site
- Oral and written consent to study participation
Who cannot join
- Tuberculosis therapy >1 week
- Inability to follow the study requirements
- Patient in custodianship or guardianship
- Other lung diseases that are not listed in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.
Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown.
Read more
This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection.
The study is comparing 3 groups of patients:
- patients with confirmed active pulmonary tuberculosis (n=20)
- patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20)
- healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured.
Hypothesis:
The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Volatile organic compounds, exhaled breath, Siemens
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tuberculosis group | Patients with confirmed pulmonary infection with M. tuberculosis. At least 50% of the subjects should be tested before therapy is started. Patients with treatment for tuberculosis >1 week are excluded. | |
| Inflammation group | Patients with another inflammatory disease of the lower respiratory tract, i.e. pneumonia, sarcoid or bronchial carcinoma. This group is required to detect VOC pattern caused by pulmonary inflammation. | |
| Healthy group | Healthy subjects without lung disease. These subjects should be recruited from outside the hospital / study site to avoid confounding VOC pattern caused by continuous exposure to the hospital environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correctly identified patients with tuberculosis
The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers
Measured: Day of admission to hospital
Secondary outcomes (3)
Change in VOC pattern induced by storage for several days
Measured: At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by storage temperature
Measured: At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by tuberculosis therapy
Measured: After completion of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporate Technologies
- Responsible party
- Principal investigator, Christian Herzmann, Research Center Borstel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748357
- Sponsor's protocol ID
- RCBorstel003
- Status last verified
- Nov 2014
- First submitted
- 7 Dec 2012
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT01748357
- Acronym / sponsor ID
- RCBorstel003
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Volatile organic compounds, exhaled breath, Siemens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Collaborators
- Siemens Corporate Technologies
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Dec 2012 (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.
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.
Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown.
This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection.
The study is comparing 3 groups of patients:
- patients with confirmed active pulmonary tuberculosis (n=20)
- patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20)
- healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured.
Hypothesis:
The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tuberculosis group | – | –Patients with confirmed pulmonary infection with M. tuberculosis. At least 50% of the subjects should be tested before therapy is started. Patients with treatment for tuberculosis >1 week are excluded. |
| Inflammation group | – | –Patients with another inflammatory disease of the lower respiratory tract, i.e. pneumonia, sarcoid or bronchial carcinoma. This group is required to detect VOC pattern caused by pulmonary inflammation. |
| Healthy group | – | –Healthy subjects without lung disease. These subjects should be recruited from outside the hospital / study site to avoid confounding VOC pattern caused by continuous exposure to the hospital environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- See groups described above
Key inclusion criteria (2 listed)
- Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or healthy subject that is not employed or working at the study site
- Oral and written consent to study participation
Key exclusion criteria (4 listed)
- Tuberculosis therapy >1 week
- Inability to follow the study requirements
- Patient in custodianship or guardianship
- Other lung diseases that are not listed in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of correctly identified patients with tuberculosis
Time frame: Day of admission to hospital
The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers
3 secondary outcomes
Change in VOC pattern induced by storage for several days
Time frame: At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by storage temperature
Time frame: At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by tuberculosis therapy
Time frame: After completion of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Research Center Borstel at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 6 Nov 2014. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of correctly identified patients with tuberculosis (time frame: Day of admission to hospital). 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 6 Nov 2014.