Research Center Borstel
Borstel, Schleswig-Holstein, 23845, Germany
NCT Number: NCT01748357
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 A further trial was closed in June 2011 but remains unpublished, yet.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
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Notify Me18 year and older
All sexes
Observational
Borstel, Schleswig-Holstein, 23845, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At days 3, 5 and 7 after sample collection
Time frame: At days 3, 5 and 7 after sample collection
Time frame: After completion of recruitment
Research Center Borstel
Other
Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
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