Siemens VOC TB Pilot Study
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Purpose
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 A further trial was closed in June 2011 but remains unpublished, yet.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
| Condition |
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Tuberculosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis |
- Percentage of correctly identified patients with tuberculosis [ Time Frame: Day of admission to hospital ] [ Designated as safety issue: No ]The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers
- Change in VOC pattern induced by storage for several days [ Time Frame: At days 3, 5 and 7 after sample collection ] [ Designated as safety issue: No ]
- Change in VOC pattern induced by storage temperature [ Time Frame: At days 3, 5 and 7 after sample collection ] [ Designated as safety issue: No ]
- Change in VOC pattern induced by tuberculosis therapy [ Time Frame: After completion of recruitment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Volatile compounds from exhaled breath
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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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.
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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.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
See groups described above
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations| Germany | |
| Research Center Borstel | Recruiting |
| Borstel, Schleswig-Holstein, Germany, 23845 | |
| Contact: Christian Herzmann, MD +49-4537-188 ext 8080 studienzentrum@fz-borstel.de | |
| Sub-Investigator: Christian Herzmann, MD | |
| Principal Investigator: Christoph Lange, MD | |
More Information
No publications provided
| Responsible Party: | Christian Herzmann, Head of Center for Clinical Trials, Research Center Borstel |
| ClinicalTrials.gov Identifier: | NCT01748357 History of Changes |
| Other Study ID Numbers: | RCBorstel003 |
| Study First Received: | December 7, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Germany: Ethics Committee University of Luebeck |
Keywords provided by Research Center Borstel:
|
Tuberculosis Volatile organic compounds exhaled breath Siemens |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 22, 2013