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

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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Key information

Conditions

Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiration Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajit Lalvani

Paddington, W2 1PG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: S-CAP

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Nov 15, 2016
Registry last updated: May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed