Epidemiology and Clinical Presentation of H1N1 Infection... | NCT01022931

Studies
Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva

NCT01022931

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Dec 11, 2012Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Healthy
Immunosuppressed
Asthmatic
Neuromuscular Diseases

Interventions

Not provided

Countries

Switzerland

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

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

Dec 10, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klara M. Pósfay Barbe, Head of Pediatric Infectious Diseases, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.

Detailed Description

Not provided

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ABCB1 polymorphisms	ABCB1 gene polymorphisms and neuropsychiatric adverse events in oseltamivir-treated children during influenza H1N1/09 pandemia	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspicion of H1N1 infection

Exclusion Criteria:

Not available for a 30 days follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Children seen at the emergency ward

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klara M Posfay-Barbe, MD, MS	University Hospitals of Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Geneva, HUG		Geneva	Canton of Geneva	1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D009468	Neuromuscular Diseases
D009976	Orthomyxoviridae Infections

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided