- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01748357
Siemens VOC TB Pilot Study
Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
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 A further trial was closed in June 2011 but remains unpublished, yet.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
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Schleswig-Holstein
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Borstel, Schleswig-Holstein, Tyskland, 23845
- Research Center Borstel
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of correctly identified patients with tuberculosis
Tidsram: 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
|
Day of admission to hospital
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in VOC pattern induced by storage for several days
Tidsram: At days 3, 5 and 7 after sample collection
|
At days 3, 5 and 7 after sample collection
|
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Change in VOC pattern induced by storage temperature
Tidsram: At days 3, 5 and 7 after sample collection
|
At days 3, 5 and 7 after sample collection
|
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Change in VOC pattern induced by tuberculosis therapy
Tidsram: After completion of recruitment
|
After completion of recruitment
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RCBorstel003
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