InfluenzaNCT00798421
Study to Evaluate Nosocomial Transmission of Influenza
An observational study of Influenza, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. The goal is to develop a transmission that can then be used to assess interventions to prevent transmission Research objectives: To develop a model to investigate… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to May 2009
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Healthy subject volunteers > 18 years of age 2. Children with confirmed influenza presenting to the Children's Hospital, Leicester Royal Infirmary
Who may be able to join
- Infected Children
- Age < 16 years
- Parents or legal guardians willing to give informed written consent
- Presenting with a febrile illness confirmed as influenza by near patient rapid antigen testing
- Healthy volunteers
- Willing to give informed written consent
Who cannot join
- Children
- No parents or legal guardians able to give informed consent
- Healthy volunteers
- known allergy to oseltamivir or zanamivir
- presence of underlying condition or concomitant therapy requiring dose alteration of oseltamivir (severe renal or hepatic failure; methotrexate and probenecid)
- underlying immunosuppressive disorder
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- known galactose intolerance
- underlying chronic medical condition known to increase risk of influenza-related complications (including asthma, chronic pulmonary airways disease, chronic cardiovascular disease, diabetes mellitus, chronic neurological disorder)
- inability or contraindication to collection of nasal swabs
- previous influenza vaccination within 2 years
- current smoker
- pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Leicester
Leicester, Leics, LE1 5WW
Iain Stephenson, FRCP, +44 116 2586952, iain.stephenson@uhl-tr.nhs.uk
About this study
Official title: Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza
The purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. The goal is to develop a transmission that can then be used to assess interventions to prevent transmission
Research objectives:
To develop a model to investigate the frequency of influenza transmission from an infected child to a susceptible health care worker
Research Hypotheses:
Influenza viruses can be transmitted from infected children to exposed health care workers
Read the detailed description
CHildren with influenza infection presenting to ED will be identified by RAT. Healthy healthcare worker subjects will expose themselves and perform specific activities with the child.
subjects will be followed by diary card, clinical symptom scores and virology swabs to assess frequency of transmission
- Conditions
- Influenza
- Keywords
- Influenza, transmission
- Medical subject headings
- Influenza, Human
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 |
|---|---|---|
| Heathcare worker | health care worker exposed to patient with influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of transmission of influenza
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Investigators
- Iain Stephenson, FRCP, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798421
- Sponsor's protocol ID
- UHL10421
- Other IDs
- REC 07/H0402/59
- Status last verified
- Nov 2008
- First submitted
- 25 Nov 2008
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza
- ClinicalTrials.gov ID
- NCT00798421
- Acronym / sponsor ID
- UHL10421
- Conditions
- Influenza
- Keywords
- Influenza, transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 26 Nov 2008 (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.
The purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. The goal is to develop a transmission that can then be used to assess interventions to prevent transmission
Research objectives:
To develop a model to investigate the frequency of influenza transmission from an infected child to a susceptible health care worker
Research Hypotheses:
Influenza viruses can be transmitted from infected children to exposed health care workers
Detailed description
CHildren with influenza infection presenting to ED will be identified by RAT. Healthy healthcare worker subjects will expose themselves and perform specific activities with the child.
subjects will be followed by diary card, clinical symptom scores and virology swabs to assess frequency of transmission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heathcare worker | – | –health care worker exposed to patient with influenza |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Healthy subject volunteers > 18 years of age 2. Children with confirmed influenza presenting to the Children's Hospital, Leicester Royal Infirmary
Key inclusion criteria (6 listed)
- Infected Children
- Healthy volunteers
Key exclusion criteria (12 listed)
- Children
- Healthy volunteers
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
Frequency of transmission of influenza
Time frame: 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2008.
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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.
Iain Stephenson, FRCP principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by University Hospitals, Leicester at 1 site 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iain Stephenson, FRCP (+44 116 258 6952, iain.stephenson@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of transmission of influenza (time frame: 1 weeks). 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 26 Nov 2008.