A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Community Acquired Pneumonia Respiration Failure Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes