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| Name | Class |
|---|---|
| Siemens Corporate Technologies | UNKNOWN |
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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 A further trial was closed in June 2011 but remains unpublished, yet.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:
Hypothesis:
The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day of admission to hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VOC pattern induced by storage for several days | At days 3, 5 and 7 after sample collection | |
| Change in VOC pattern induced by storage temperature | At days 3, 5 and 7 after sample collection |
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Inclusion Criteria:
Exclusion Criteria:
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See groups described above
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center Borstel | Borstel | Schleswig-Holstein | 23845 | Germany |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Volatile compounds from exhaled breath
| Change in VOC pattern induced by tuberculosis therapy | After completion of recruitment |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |