Study to Evaluate Nosocomial Transmission of Influenza

NCT ID: NCT00798421

Last Updated: 2008-11-26

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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

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Influenza

Keywords

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Influenza, transmission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heathcare worker

health care worker exposed to patient with influenza

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

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University of Leicester, UK

Principal Investigators

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Iain Stephenson, FRCP

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Locations

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University Hospitals Leicester

Leicester, Leics, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Iain Stephenson, FRCP

Role: CONTACT

Phone: +44 116 258 6952

Email: [email protected]

Facility Contacts

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Iain Stephenson, FRCP

Role: primary

Other Identifiers

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REC 07/H0402/59

Identifier Type: -

Identifier Source: secondary_id

UHL10421

Identifier Type: -

Identifier Source: org_study_id