Clinical trial NCT01748357: Siemens VOC TB Pilot Study
Official title: Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
Volatile organic compounds
exhaled breath
Siemens
Lead sponsor: Research Center Borstel
Sponsor class: OTHER
Collaborators: name: Siemens Corporate Technologies
First posted: 2012-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See groups described above

Brief 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 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 A further trial was closed in June 2011 but remains unpublished, yet.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


Eligibility criteria: Inclusion Criteria:

1. 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
2. Oral and written consent to study participation

Exclusion Criteria:

1. Tuberculosis therapy \>1 week
2. Inability to follow the study requirements
3. Patient in custodianship or guardianship
4. Other lung diseases that are not listed in the inclusion criteria.

Primary outcomes:
measure: Percentage of correctly identified patients with tuberculosis
timeFrame: Day of admission to hospital
Secondary outcomes:
measure: Change in VOC pattern induced by storage for several days
timeFrame: At days 3, 5 and 7 after sample collection
measure: Change in VOC pattern induced by storage temperature
timeFrame: At days 3, 5 and 7 after sample collection
measure: Change in VOC pattern induced by tuberculosis therapy
timeFrame: After completion of recruitment
Other outcomes:
Locations:
city: Borstel
country: Germany
facility: Research Center Borstel
state: Schleswig-Holstein
Study officials:
References: