A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP)
A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Paddington, Regno Unito, W2 1PG
- Ajit Lalvani
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Adults aged 18 or over
- Admitted to a participating severe respiratory failure centre or ICU
- Admitted due to community acquired pneumonia (CAP) according to clinical and radiological criteria
- Tracheal intubation, receiving mechanical ventilation +/- ECMO
- Requires bronchoscopy as part of routine diagnostic care plan
- Bronchoscopy takes place within 72 hours of first admission to hospital
Exclusion Criteria:
- Any current or previous condition/circumstance that, in the opinion of the investigator or study nurse, may put the individual at risk if participating
- Patients receiving end of life care
- Hospitalisation within the previous 28 days (not including pre-ECMO hospitalisation for ECMO patients)
- Consent or assent not given
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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SCAP requiring ECMO
Patients diagnosed with severe respiratory failure due to community acquired pneumonia that require extra-corporeal membrane oxygenation and a routine bronchoscopy for clinical purposes. Molecular laboratory techniques will be applied to residual respiratory tract samples including bronchoalveolar lavage and non-directed bronchoalveolar lavage. Comparisons will be made to conventional diagnostic tests used in the diagnosis of community acquired pneumonia. |
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SCAP requiring ITU support
Patients diagnosed with severe respiratory failure due to community acquired pneumonia that require intensive care support and undergo a routine bronchoscopy for clinical purposes. Molecular laboratory techniques will be applied to residual respiratory tract samples including bronchoalveolar lavage and non-directed bronchoalveolar lavage. Comparisons will be made to conventional diagnostic tests used in the diagnosis of community acquired pneumonia. |
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Healthy controls
Healthy volunteers who undergo bronchoscopy as part of a designated research bronchoscopy list. Molecular laboratory techniques will be applied to bronchoalveolar lavage samples. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
Lasso di tempo: 28 days (From time of enrollment up until end of inclusion)
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The proportion of pathogen genome that can be detected in bronchial lavage samples detected by the proportion of the sequenced nucleic acid which is pathogen derived and the proportion of the pathogen genome which be reconstructed.
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28 days (From time of enrollment up until end of inclusion)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques
Lasso di tempo: 28 days (From time of enrollment up until end of inclusion)
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Metagenomic sequencing data obtained will be compared to results obtained from conventional diagnostic tests undertaken as part of the participant's routine clinical care. Data will be used to evaluate the ability of each technique to detect any pathogens found. The conventional microbiological tests that will be used for comparison include those undertaken as part of the participants routine clinical care and will include urinary antigen tests (Pneumococcal and Leigonella); blood, sputum and bronchial lavage culture including polymerase chain reaction (PCR) for Legionella spp, Mycoplasma pneumoniae and Chlamydophila pneumoniae and respiratory viral PCR multiplex assays. The results of serological tests and PCR for Influenza A &B from nose and throat swabs will also be compared. |
28 days (From time of enrollment up until end of inclusion)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Ajit Lalvani, MBBS,MRCP,FRCP, Imperial College London
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SCAP2016
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