Study to Evaluate Nosocomial Transmission of Influenza

Influenza Clinical Trial

Official title:

Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00798421
• Other study ID #: UHL10421
• Secondary ID: REC 07/H0402/59
• Status: Unknown status
• Phase: N/A
• First received: November 25, 2008
• Last updated: November 25, 2008
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: November 2008
• Source: University Hospitals, Leicester
• Contact: Iain Stephenson, FRCP
• Phone: +44 116 258 6952
• Email: iain.stephenson[@]uhl-tr.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United Kingdom	University Hospitals Leicester	Leicester	Leics

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of transmission of influenza		1 weeks