Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Siemens VOC TB Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Siemens Corporate Technologies
Information provided by (Responsible Party):
Christian Herzmann, Research Center Borstel
ClinicalTrials.gov Identifier:
NCT01748357
First received: December 7, 2012
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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 A further trial was closed in June 2011 but remains unpublished, yet.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


Condition
Tuberculosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Research Center Borstel:

Primary Outcome Measures:
  • Percentage of correctly identified patients with tuberculosis [ Time Frame: Day of admission to hospital ] [ Designated as safety issue: No ]
    The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers


Secondary Outcome Measures:
  • Change in VOC pattern induced by storage for several days [ Time Frame: At days 3, 5 and 7 after sample collection ] [ Designated as safety issue: No ]
  • Change in VOC pattern induced by storage temperature [ Time Frame: At days 3, 5 and 7 after sample collection ] [ Designated as safety issue: No ]
  • Change in VOC pattern induced by tuberculosis therapy [ Time Frame: After completion of recruitment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Volatile compounds from exhaled breath


Estimated Enrollment: 60
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

See groups described above

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748357

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

No publications provided

Responsible Party: Christian Herzmann, Head of Center for Clinical Trials, Research Center Borstel
ClinicalTrials.gov Identifier: NCT01748357     History of Changes
Other Study ID Numbers: RCBorstel003
Study First Received: December 7, 2012
Last Updated: November 5, 2014
Health Authority: Germany: Ethics Committee University of Luebeck

Keywords provided by Research Center Borstel:
Tuberculosis
Volatile organic compounds
exhaled breath
Siemens

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 20, 2014