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NCT01694524 Clinical Trial

Nervous System Infections Among Patients With Febrile Seizure

Meningitis Clinical Trial

Official title:
Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01694524
Other study ID # febrile seizure and infection
Secondary ID
Status Completed
Phase N/A
First received September 24, 2012
Last updated May 19, 2014
Start date June 2013
Est. completion date March 2014

Study information
Verified date May 2014
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial Summary

Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous.

The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 5 Years
Eligibility Inclusion Criteria:

- febrile (>38°)

- Seizure

Exclusion Criteria:

- previous non febrile seizure

- known trauma

- immunodeficiancy status

- Underlying illness

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Hopital Jean Verdier Bondy
France Centre hospitalier intercommunal de creteil Creteil
France Centre hospitalier Lagny-Marne la Vallée Lagny-Sur-Marne
France Centre hospitalier de Versailles Le chesnay
France Hôpital Armand Trousseau Paris
France Hopital Robert Debré Paris
France Centre hospitalier intercommunal de Poissy Poissy

Sponsors (7)
Lead Sponsor Collaborator
Hôpital Armand Trousseau Centre hospitalier de versailles, Centre Hospitalier Intercommunal Creteil, Centre hospitalier intercommunal de Poissy, Centre hospitalier Lagny Marne la vallée, Hôpital Jean Verdier, Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bacterial meningitis Results of lumbar puncture or meningitis history in charts 7 days after emergency visit No
Primary Herpes simplex virus meningitis/encephalitis Results of lumbar puncture or meningitis history in charts 7 days after emergency visit No
Secondary emergent intracranial processus 7 days after emergency visit No
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