NCT00798421

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

November 25, 2008

Last Update Submit

November 25, 2008

Conditions

Keywords

Influenza, transmission

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

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Throat and nose swabs

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Iain Stephenson, FRCP

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

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

Locations