Siemens VOC TB Pilot Study

NCT01748357 | Completed

• 1 other identifier: RCBorstel003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 A further trial was closed in June 2011 but remains unpublished, yet.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

Conditions

Tuberculosis

Keywords

Tuberculosis; Volatile organic compounds; exhaled breath; Siemens

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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 storage temperature

  At days 3, 5 and 7 after sample collection

• Change in VOC pattern induced by tuberculosis therapy

  After completion of recruitment

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See groups described above

You may qualify if:

• 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

You may not qualify if:

• Tuberculosis therapy \>1 week
• Inability to follow the study requirements
• Patient in custodianship or guardianship

Sponsors & Collaborators

• Research Center Borstel: lead
• Siemens Corporate Technologies: collaborator

Study Sites (1)

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Volatile compounds from exhaled breath

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for Clinical Trials

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

DE (1)