- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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 A further trial was closed in June 2011 but remains unpublished, yet.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
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
-
Schleswig-Holstein
-
Borstel, Schleswig-Holstein, Alemanha, 23845
- Research Center Borstel
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of correctly identified patients with tuberculosis
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change in VOC pattern induced by storage for several days
Prazo: 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
Prazo: 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
Prazo: After completion of recruitment
|
After completion of recruitment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RCBorstel003
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .