Siemens VOC TB Pilot Study

Completed

• Conditions: Tuberculosis

• Registration Number: NCT01748357
• Lead Sponsor: 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 A further trial was closed in June 2011 but remains unpublished, yet.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.

Hypothesis:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of correctly identified patients with tuberculosis	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

Name	Time	Method
Change in VOC pattern induced by storage temperature	At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by storage for several days	At days 3, 5 and 7 after sample collection
Change in VOC pattern induced by tuberculosis therapy	After completion of recruitment

Trial Locations

Locations (1)

Research Center Borstel; 🇩🇪 Borstel, Schleswig-Holstein, Germany