Virus Shedding and Environmental Deposition of a Novel Influenza Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046734
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

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 or disease
Novel (H1N1) Influenza

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Virus Shedding and Environmental Deposition of Novel A(H1N1) Pandemic Influenza Virus
Study Start Date : September 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Adult Community
Adult Hospital
Children Hospital
Children Community

Primary Outcome Measures :
  1. Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR). [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT01046734

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
Principal Investigator: Jonathan Van-Tam, MD University of Nottingham

Responsible Party: University of Nottingham Identifier: NCT01046734     History of Changes
Other Study ID Numbers: 09061
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by University of Nottingham:
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