Novel (H1N1) InfluenzaNCT01046734
Virus Shedding and Environmental Deposition of a Novel Influenza Virus
An observational study of Novel (H1N1) Influenza, run by University of Nottingham at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Novel (H1N1) Influenza
- How many people
- 105 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children with swine flu whi have had symptoms for less than 3 days
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Leicester University Hospitals NHS Trust
Leicester
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Sheffield Teaching Hospitals NHS Trust
Sheffield
About this study
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.
- Conditions
- Novel (H1N1) Influenza
- Keywords
- Influenza, virus shedding, infection control, swine flu
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Community | Not described | |
| Adult Hospital | Not described | |
| Children Hospital | Not described | |
| Children Community | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel (H1N1) InfluenzaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Van-Tam, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046734
- Sponsor's protocol ID
- 09061
- Status last verified
- Sep 2012
- First submitted
- 11 Jan 2010
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus Shedding and Environmental Deposition of Novel A(H1N1) Pandemic Influenza Virus
- ClinicalTrials.gov ID
- NCT01046734
- Acronym / sponsor ID
- 09061
- Conditions
- Novel (H1N1) Influenza
- Keywords
- Influenza, virus shedding, infection control, swine flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Community | – | – |
| Adult Hospital | – | – |
| Children Hospital | – | – |
| Children Community | – | – |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with swine flu whi have had symptoms for less than 3 days
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Van-Tam, MD principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel (H1N1) Influenza, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.