Mechanisms of Severe Acute Influenza Consortium (MOSAIC)

This study has been completed.
Sponsor:
Collaborators:
Wellcome Trust
Medical Research Council
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00965354
First received: August 24, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.

We 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 largescale 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.

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. 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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Severe Acute Influenza Consortium (MOSAIC)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Detailed clinical phenotype. Clinicopathological correlation will then be sought between the clinical phenotype and pathological parameters measured as per work packages. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to drug treatment and the effect of drug resistance if that emerges. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

A) Swabs and secretions from the nose and throat B) Blood C) Sputum D) Urine E) Stool

In addition, if the patients are having further respiratory sample collection as part of their routine care, for example tracheal aspirates, bronchial lavage and other samples then we would like to take an additional amount of these samples for our research.


Enrollment: 257
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Influenza diagnosis
Patients admitted to hospital with a suspected or confirmed influenza diagnosis on admission

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital admissions

Criteria

Inclusion Criteria:

  • Any patient admitted to hospital with suspected or confirmed influenza infection

Exclusion Criteria:

  • Patients who do not give their consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965354

Locations
United Kingdom
Aintree Hospitals NHS Trust
Liverpool, United Kingdom, L9 7AL
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Liverpool Women's NHS Foundation Trust
Liverpool, United Kingdom, L8 7SS
Alder Hey Children's Foundation NHS Trust
Liverpool, United Kingdom, L12 2AP
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG
Wirral University Teaching Hospital NHS Foundation Trust
Wirral, United Kingdom, CH49 5PE
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Medical Research Council
Investigators
Principal Investigator: Peter JM Openshaw Imperial College London
  More Information

No publications provided

Responsible Party: Prof Peter Openshaw, Imperial College London
ClinicalTrials.gov Identifier: NCT00965354     History of Changes
Other Study ID Numbers: CRO1367, 09/H0709/52, 09/MRE00/67
Study First Received: August 24, 2009
Last Updated: June 22, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
severe
acute
influenza
consortium
swine
flu
influenza A
H1N1
hospital
admission

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014