Virus Shedding and Environmental Deposition of a Novel Influenza Virus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01046734
First received: January 11, 2010
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

An influenza pandemic has recently been declared, involving the novel A(H1N1) 'swine flu' virus. This has spread to almost 100 countries worldwide in less than two months, causing widespread disease so far in Mexico, USA and Canada. It is highly likely that over the next 12 months, many countries including the UK will be affected by widespread illness. In the UK this wave of intense flu activity is most likely to occur in late autumn 2009.

Very little is known about the new H1N1 pandemic virus. For example we do not know how long the virus is excreted by infected humans and how much virus is spread to surfaces and carried in the air. This is very important to know as soon as possible because it affects the advice that will be given to healthcare workers about controlling the spread of infection to themselves and other patients. Similarly we need this information so we can give good quality advice to families who will have to look after each other in their own homes.

The best way to obtain this information is to ask patients who get pandemic flu soon (in August, September and October) to help us by agreeing to give a daily nose swab sample for just over one week so we can see how much virus is in the nose day by day and how quickly this disappears. At the same time we will take samples from hard surfaces in a patient's room or home and sample the air using a special filter device. We can then work out how much virus is being excreted, how long the 'danger period' is, whether surfaces are more or less important than the air that we breathe (in terms of catching the virus) and if we can advise on a 'safe distance' from the patient, beyond which there is relatively little chance of catching the illness.


Condition
Novel (H1N1) Influenza

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Virus Shedding and Environmental Deposition of Novel A(H1N1) Pandemic Influenza Virus

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult Community
Adult Hospital
Children Hospital
Children Community

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults and children with swine flu whi have had symptoms for less than 3 days

Criteria

Inclusion Criteria:

  • Subject fulfils case definition
  • Informed consent obtained (from Parent/Guardian where appropriate)
  • Age >1 month
  • Near-patient test positive for influenza A or other substantive test positive for influenza A (including 'swine flu')
  • Willing to participate and agrees to allow both nasal and environmental samples to be taken

Exclusion Criteria:

  • Illness for >48h (community cases)
  • Illness for >96h (hospital cases)
  • Existing case of ILI in the household
  • A negative for swine flu (as part of NHS care)
  • Has taken part in influenza research involving an investigational medicinal product within the last 3 months
  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: NCT01046734

Locations
United Kingdom
Leicester University Hospitals NHS Trust
Leicester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Jonathan Van-Tam, MD University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01046734     History of Changes
Other Study ID Numbers: 09061
Study First Received: January 11, 2010
Last Updated: September 26, 2012
Health Authority: United Kingdom: Department of Health
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Influenza
virus shedding
infection control
swine flu

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 October 19, 2014