Study to Evaluate Nosocomial Transmission of Influenza
Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza
2 other identifiers
observational
50
1 country
1
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 26, 2008
November 1, 2008
4 months
November 25, 2008
November 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of transmission of influenza
1 weeks
Study Arms (1)
Heathcare worker
health care worker exposed to patient with influenza
Eligibility Criteria
1. Healthy subject volunteers \> 18 years of age 2. Children with confirmed influenza presenting to the Children's Hospital, Leicester Royal Infirmary
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leicester
Leicester, Leics, LE1 5WW, United Kingdom
Biospecimen
Throat and nose swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iain Stephenson, FRCP
University Hospitals, Leicester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
November 26, 2008
Record last verified: 2008-11