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

Imperial College London

Status: Completed

Conditions: Pneumonia; Respiration Failure; Community Acquired Pneumonia

Study type: Observational

Funder types: Other

Identifiers

NCT02963142

SCAP2016

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

103 participants in 3 patient groups

SCAP requiring ECMO

Description:

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

Description:

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

Description:

Healthy volunteers who undergo bronchoscopy as part of a designated research bronchoscopy list. Molecular laboratory techniques will be applied to bronchoalveolar lavage samples.