NCT01022931

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

November 30, 2009

Last Update Submit

December 10, 2012

Conditions

Keywords

Influenza A H1N1ChildrenEpidemiologyTreatmentOseltamivirGenetics

Outcome Measures

Primary Outcomes (1)

  • ABCB1 polymorphisms

    ABCB1 gene polymorphisms and neuropsychiatric adverse events in oseltamivir-treated children during influenza H1N1/09 pandemia

    6 months

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children seen at the emergency ward

You may qualify if:

  • suspicion of H1N1 infection

You may not qualify if:

  • Not available for a 30 days follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Geneva, HUG

Geneva, Canton of Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swab; DNA for genetic polymorphisms (Response to oseltamivir)

MeSH Terms

Conditions

AsthmaNeuromuscular DiseasesOrthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNervous System DiseasesRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Klara M Posfay-Barbe, MD, MS

    University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Infectious Diseases

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2010

Study Completion

July 1, 2012

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations