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)
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Paddington, Vereinigtes Königreich, W2 1PG
- Ajit Lalvani
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Ajit Lalvani, MBBS,MRCP,FRCP, Imperial College London
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SCAP2016
Plan für individuelle Teilnehmerdaten (IPD)
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