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 A further trial was closed in June 2011 but remains unpublished, yet.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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Schleswig-Holstein
-
Borstel, Schleswig-Holstein, Allemagne, 23845
- Research Center Borstel
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of correctly identified patients with tuberculosis
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in VOC pattern induced by storage for several days
Délai: At days 3, 5 and 7 after sample collection
|
At days 3, 5 and 7 after sample collection
|
|
Change in VOC pattern induced by storage temperature
Délai: At days 3, 5 and 7 after sample collection
|
At days 3, 5 and 7 after sample collection
|
|
Change in VOC pattern induced by tuberculosis therapy
Délai: After completion of recruitment
|
After completion of recruitment
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RCBorstel003
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .