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OpenTrials
Completed

NCT Number: NCT01748357

Siemens VOC TB Pilot Study

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 A further trial was closed in June 2011 but remains unpublished, yet.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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Oral and written consent to study participation

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Collaborators

  • Siemens Corporate Technologies

Registry information

Official study title

Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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