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Study to Evaluate Nosocomial Transmission of Influenza

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by University Hospitals, Leicester.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00798421
First received: November 25, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Frequency of transmission of influenza [ Time Frame: 1 weeks ]

Biospecimen Retention:   Samples Without DNA
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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Hospitals Leicester Not yet recruiting
Leicester, Leics, United Kingdom, LE1 5WW
Contact: Iain Stephenson, FRCP    +44 116 2586952    iain.stephenson@uhl-tr.nhs.uk   
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: Iain Stephenson, FRCP University Hospitals, Leicester
  More Information

Responsible Party: Iain Stephenson, University of Leicester, UK
ClinicalTrials.gov Identifier: NCT00798421     History of Changes
Other Study ID Numbers: UHL10421
REC 07/H0402/59
Study First Received: November 25, 2008
Last Updated: November 25, 2008

Keywords provided by University Hospitals, Leicester:
Influenza, transmission

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 25, 2017