Tuberculosis Clinical Trial
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June 2011 but remains unpublished, yet.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.
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
n/a
Observational Model: Case Control, Time Perspective: Prospective
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