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Siemens VOC TB Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748357
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : November 6, 2014
Siemens Corporate Technologies
Information provided by (Responsible Party):
Christian Herzmann, Research Center Borstel

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 A further trial was closed in June 2011 but remains unpublished, yet.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


The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis

Condition or disease

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Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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.

Primary Outcome Measures :
  1. Percentage of correctly identified patients with tuberculosis [ 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

Secondary Outcome Measures :
  1. Change in VOC pattern induced by storage for several days [ Time Frame: At days 3, 5 and 7 after sample collection ]
  2. Change in VOC pattern induced by storage temperature [ Time Frame: At days 3, 5 and 7 after sample collection ]
  3. Change in VOC pattern induced by tuberculosis therapy [ Time Frame: After completion of recruitment ]

Biospecimen Retention:   Samples Without DNA
Volatile compounds from exhaled breath

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
See groups described above

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748357

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Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845
Sponsors and Collaborators
Research Center Borstel
Siemens Corporate Technologies

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Responsible Party: Christian Herzmann, Head of Center for Clinical Trials, Research Center Borstel Identifier: NCT01748357    
Other Study ID Numbers: RCBorstel003
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Keywords provided by Christian Herzmann, Research Center Borstel:
Volatile organic compounds
exhaled breath
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections