Novel (H1N1) Influenza Clinical Trial
Official title:
Virus Shedding and Environmental Deposition of Novel A(H1N1) Pandemic Influenza Virus
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.
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | March 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Leicester University Hospitals NHS Trust | Leicester | |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
| United Kingdom | Sheffield Teaching Hospitals NHS Trust | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR). | 6 months | No |