InfluenzaMOSAICNCT00965354
Mechanisms of Severe Acute Influenza Consortium (MOSAIC)
An observational study of Influenza, run by Imperial College London at 8 sites in United Kingdom.
Trial summary
The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- How many people
- 131 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Dec 2009to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital admissions
Who may be able to join
- Any patient admitted to hospital with suspected or confirmed influenza infection
Who cannot join
- Patients who do not give their consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Alder Hey Children's Foundation NHS Trust
Liverpool, L12 2AP
Royal Liverpool University Hospital
Liverpool, L7 8XP
Liverpool Women's NHS Foundation Trust
Liverpool, L8 7SS
Aintree Hospitals NHS Trust
Liverpool, L9 7AL
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
Imperial College Healthcare NHS Trust
London, W2 1PG
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, CH49 5PE
About this study
The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. By integrating the information that we will gather, we will create a unique overview of how influenza causes illness and what might be done to improve patient management.
Read the detailed description
Influenza A is one of the best studied viruses, but continues to have a very large impact on human and animal health. In addition to causing outbreaks of winter flu, it sometimes mutates to create a new virus that spreads quickly around the world. It is puzzling that the same virus appears to cause minor or absent symptoms in some people while killing others. Much remains to be understood.
The investigators have assembled an unprecedented group of internationally renowned scientists from England and Scotland who will together focus on studying a few hundred people hospitalised during the current swine flu pandemic. Such a large scale project has never before been attempted, but we are now poised to work together and integrate the many recent advances in biomedical science that relate to understanding how influenza causes disease.
- Conditions
- Influenza
- Keywords
- severe, acute, influenza, consortium, swine, flu, influenza A, H1N1, hospital, admission
- Medical subject headings
- Influenza, Human, Lymphoma, Follicular
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 |
|---|---|---|
| Influenza diagnosis | Patients admitted to hospital with a suspected or confirmed influenza diagnosis on admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clinical Phenotype Presenting Also a Sequential Activation of Immune/Infammatory Pathways.
Detailed clinical phenotype. Clinicopathological correlation will then be sought between the clinical phenotype and pathological parameters measured as per work packages.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Peter JM Openshaw, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965354
- Sponsor's protocol ID
- CRO1367
- Other IDs
- 09/H0709/52, 09/MRE00/67
- Acronym
- MOSAIC
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2009
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunning J, Blankley S, Hoang LT, Cox M, Graham CM, James PL, Bloom CI, Chaussabel D, Banchereau J, Brett SJ, Moffatt MF, O'Garra A, Openshaw PJM; MOSAIC Investigators. Progression of whole-blood transcriptional signatures from interferon-induced to neutrophil-associated patterns in severe influenza. Nat Immunol. 2018 Jun;19(6):625-635. doi: 10.1038/s41590-018-0111-5. Epub 2018 May 18.
PubMed 29777224Dunning J, Blankley S, Hoang LT, Cox M, Graham CM, James PL, Bloom CI, Chaussabel D, Banchereau J, Brett SJ; MOSAIC Investigators; Moffatt MF, O'Garra A, Openshaw PJM. Author Correction: Progression of whole-blood transcriptional signatures from interferon-induced to neutrophil-associated patterns in severe influenza. Nat Immunol. 2019 Mar;20(3):373. doi: 10.1038/s41590-019-0328-y.
PubMed 30728492
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Severe Acute Influenza Consortium (MOSAIC)
- ClinicalTrials.gov ID
- NCT00965354
- Acronym / sponsor ID
- MOSAIC / CRO1367
- Conditions
- Influenza
- Keywords
- severe, acute, influenza, consortium, swine, flu, influenza A, H1N1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council
- Study start
- Dec 2009 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. By integrating the information that we will gather, we will create a unique overview of how influenza causes illness and what might be done to improve patient management.
Detailed description
Influenza A is one of the best studied viruses, but continues to have a very large impact on human and animal health. In addition to causing outbreaks of winter flu, it sometimes mutates to create a new virus that spreads quickly around the world. It is puzzling that the same virus appears to cause minor or absent symptoms in some people while killing others. Much remains to be understood.
The investigators have assembled an unprecedented group of internationally renowned scientists from England and Scotland who will together focus on studying a few hundred people hospitalised during the current swine flu pandemic. Such a large scale project has never before been attempted, but we are now poised to work together and integrate the many recent advances in biomedical science that relate to understanding how influenza causes disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza diagnosis | – | –Patients admitted to hospital with a suspected or confirmed influenza diagnosis on admission |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital admissions
Key inclusion criteria (1 listed)
- Any patient admitted to hospital with suspected or confirmed influenza infection
Key exclusion criteria (1 listed)
- Patients who do not give their consent
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
Number of Patients With Clinical Phenotype Presenting Also a Sequential Activation of Immune/Infammatory Pathways.
Time frame: 15 months
Detailed clinical phenotype. Clinicopathological correlation will then be sought between the clinical phenotype and pathological parameters measured as per work packages.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29777224Dunning J, Blankley S, Hoang LT, Cox M, Graham CM, James PL, Bloom CI, Chaussabel D, Banchereau J, Brett SJ, Moffatt MF, O'Garra A, Openshaw PJM; MOSAIC Investigators. Progression of whole-blood transcriptional signatures from interferon-induced to neutrophil-associated patterns in severe influenza. Nat Immunol. 2018 Jun;19(6):625-635. doi: 10.1038/s41590-018-0111-5. Epub 2018 May 18.
- Results publication: PubMed 30728492Dunning J, Blankley S, Hoang LT, Cox M, Graham CM, James PL, Bloom CI, Chaussabel D, Banchereau J, Brett SJ; MOSAIC Investigators; Moffatt MF, O'Garra A, Openshaw PJM. Author Correction: Progression of whole-blood transcriptional signatures from interferon-induced to neutrophil-associated patterns in severe influenza. Nat Immunol. 2019 Mar;20(3):373. doi: 10.1038/s41590-019-0328-y.
- Individual participant dataSharing planned: No
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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.
Peter JM Openshaw principal investigator
Imperial College London
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Imperial College London at 8 sites 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 1 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Clinical Phenotype Presenting Also a Sequential Activation of Immune/Infammatory Pathways. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965354, which also lists 2 linked publications.
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 19 Sep 2024.