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A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP)

1. maj 2019 opdateret af: Imperial College London

A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)

Severe community acquired pneumonia is common and associated with high mortality. Conventional microbiological diagnostics identify pathogens in approximately half of cases, which is inadequate for both clinical and epidemiological purposes. This study applies next-generation sequencing based metagenomic techniques to patients with extremely severe community acquired pneumonia, to investigate the microbiome of severe community acquired pneumonia and evaluate metagenomic approaches as diagnostic tools.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

103

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults admitted to Extra-Corporeal Membrane Oxygenation (ECMO) and Intensive Care Units (ICU) centres in England for severe community-acquired pneumonia

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
Tidsramme: 28 days (From time of enrollment up until end of inclusion)
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.
28 days (From time of enrollment up until end of inclusion)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques
Tidsramme: 28 days (From time of enrollment up until end of inclusion)

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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Imperial College London

Samarbejdspartnere

NIHR HPRU in Respiratory Infections

Efterforskere

  • Studiestol: Ajit Lalvani, MBBS,MRCP,FRCP, Imperial College London

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2016

Primær færdiggørelse (Faktiske)

1. oktober 2018

Studieafslutning (Faktiske)

1. oktober 2018

Datoer for studieregistrering

Først indsendt

27. oktober 2016

Først indsendt, der opfyldte QC-kriterier

9. november 2016

Først opslået (Skøn)

15. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2019

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCAP2016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner