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

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ClinicalTrials.gov Identifier: NCT02963142
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
NIHR HPRU in Respiratory Infections
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease
Community Acquired Pneumonia Respiration Failure Pneumonia

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
whole blood, serum, bronchoalveolar lavage,nose and throat swab and oropharyngeal swabs.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963142


Locations
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United Kingdom
Ajit Lalvani
Paddington, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
NIHR HPRU in Respiratory Infections
Investigators
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Study Chair: Ajit Lalvani, MBBS,MRCP,FRCP Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02963142     History of Changes
Other Study ID Numbers: SCAP2016
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Imperial College London:
Intensive care
Extra-corporeal membrane oxygenation (ECMO)
Severe Respiratory Infections
Sequencing
Metagenome
Diagnosis
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders