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

NCT02963142 | Completed

• 1 other identifier: SCAP2016
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Acquired Pneumonia; Respiration Failure; Pneumonia

Keywords

Intensive care; Extra-corporeal membrane oxygenation (ECMO); Severe Respiratory Infections; Sequencing; Metagenome; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples

  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)

Secondary Outcomes (1)

• 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 Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Ajit Lalvani

Paddington, W2 1PG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, bronchoalveolar lavage,nose and throat swab and oropharyngeal swabs.

MeSH Terms

Conditions

Community-Acquired Pneumonia; Respiratory Insufficiency; Pneumonia; Respiratory Tract Infections; Disease

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ajit Lalvani, MBBS,MRCP,FRCP

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 15, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 2, 2019

Record last verified: 2018-08

Locations

GB (1)