Study to Evaluate Nosocomial Transmission of Influenza | NCT00798421

Studies
Study to Evaluate Nosocomial Transmission of Influenza

NCT00798421

Sponsor

University Hospitals, Leicester

Status

Unknown status

Last Update Posted

Nov 26, 2008Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Influenza

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
REC 07/H0402/59

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

May 2009Estimated

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Nov 25, 2008

First Posted Date

Nov 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2008

Last Update Posted Date

Nov 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Heathcare worker		health care worker exposed to patient with influenza

Measure	Description	Time Frame
Frequency of transmission of influenza		1 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Iain Stephenson, FRCP	Contact	+44 116 258 6952		iain.stephenson@uhl-tr.nhs.uk

Overall Officials

Name	Affiliation	Role
Iain Stephenson, FRCP	University Hospitals, Leicester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leicester		Leicester	Leics	LE1 5WW	United Kingdom

Type	Date	Date Unknown
Release	Feb 20, 2013
Reset	Mar 29, 2013
Release	Jun 24, 2013
Reset	Jun 24, 2013
Release	Dec 3, 2014
Reset	Dec 3, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 20, 2013			Mar 29, 2013
Jun 24, 2013

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections