Siemens VOC TB Pilot Study

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748357
• Other study ID #: RCBorstel003
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: November 5, 2014
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Research Center Borstel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee University of Luebeck
• Study type: Observational

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 A further trial was closed in June 2011 but remains unpublished, yet.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Germany	Research Center Borstel	Borstel	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Research Center Borstel	Siemens Corporate Technologies

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of correctly identified patients with tuberculosis	The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers	Day of admission to hospital	No
Secondary	Change in VOC pattern induced by storage for several days		At days 3, 5 and 7 after sample collection	No
Secondary	Change in VOC pattern induced by storage temperature		At days 3, 5 and 7 after sample collection	No
Secondary	Change in VOC pattern induced by tuberculosis therapy		After completion of recruitment	No