Community Acquired PneumoniaS-CAPNCT02963142
A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia
An observational study of Community Acquired Pneumonia and Respiration Failure, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Acquired Pneumonia, Respiration Failure, Pneumonia
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults admitted to Extra-Corporeal Membrane Oxygenation (ECMO) and Intensive Care Units (ICU) centres in England for severe community-acquired pneumonia
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
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
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Insufficiency, Pneumonia, Respiratory Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 28 days (From time of enrollment up until end of inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ajit Lalvani, MBBS,MRCP,FRCP, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963142
- Sponsor's protocol ID
- SCAP2016
- Acronym
- S-CAP
- Status last verified
- Aug 2018
- First submitted
- 27 Oct 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
- ClinicalTrials.gov ID
- NCT02963142
- Acronym / sponsor ID
- S-CAP / SCAP2016
- Conditions
- Community Acquired Pneumonia, Respiration Failure, Pneumonia
- Keywords
- Intensive care, Extra-corporeal membrane oxygenation (ECMO), Severe Respiratory Infections, Sequencing, Metagenome, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to Extra-Corporeal Membrane Oxygenation (ECMO) and Intensive Care Units (ICU) centres in England for severe community-acquired pneumonia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajit Lalvani, MBBS,MRCP,FRCP study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia and Respiration Failure, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples (time frame: 28 days (From time of enrollment up until end of inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.