Virus Shedding and Environmental Deposition of a Novel Influenza Virus

NCT ID: NCT01046734

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Novel (H1N1) Influenza

Keywords

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Influenza virus shedding infection control swine flu

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Community

No interventions assigned to this group

Adult Hospital

No interventions assigned to this group

Children Hospital

No interventions assigned to this group

Children Community

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Van-Tam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Leicester University Hospitals NHS Trust

Leicester, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Sheffield Teaching Hospitals NHS Trust

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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09061

Identifier Type: -

Identifier Source: org_study_id