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Clinical Trials/NCT02963142
NCT02963142
Completed
Not Applicable

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

Imperial College London1 site in 1 country103 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Community Acquired Pneumonia
Sponsor
Imperial College London
Enrollment
103
Locations
1
Primary Endpoint
Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
October 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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