Study to Evaluate Nosocomial Transmission of Influenza - Full Text View

Sponsored by:	University Hospitals, Leicester
Information provided by:	University Hospitals, Leicester
ClinicalTrials.gov Identifier:	NCT00798421

Purpose

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

Condition
Influenza

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:

Frequency of transmission of influenza [ Time Frame: 1 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Throat and nose swabs

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Heathcare worker health care worker exposed to patient with influenza

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy subject volunteers > 18 years of age
Children with confirmed influenza presenting to the Children's Hospital, Leicester Royal Infirmary

Criteria

Inclusion criteria:

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

Exclusion criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798421

Contacts

Contact: Iain Stephenson, FRCP

+44 116 258 6952

iain.stephenson@uhl-tr.nhs.uk

Locations

United Kingdom, Leics
University Hospitals Leicester
Leicester, Leics, United Kingdom, LE1 5WW

Sponsors and Collaborators

University Hospitals, Leicester

Investigators

Principal Investigator:

Iain Stephenson, FRCP

University Hospitals, Leicester

More Information

No publications provided

Responsible Party:	University of Leicester, UK ( Iain Stephenson )
Study ID Numbers:	UHL10421, REC 07/H0402/59
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798421 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospitals, Leicester:

Influenza, transmission

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009