Nervous System Infections Among Patients With Febrile Sei... | NCT01694524

Studies
Nervous System Infections Among Patients With Febrile Seizure

NCT01694524

Sponsor

Hôpital Armand Trousseau

Status

Completed

Last Update Posted

May 20, 2014Estimated

Enrollment

1,200Actual

Phase

Not provided

Conditions

Seizure
Febrile Seizure
Meningitis
Encephalitis

Interventions

Not provided

Countries

France

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

May 2014

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

Jun 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Sep 24, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 27, 2012Estimated

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

May 19, 2014

Last Update Posted Date

May 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

CARBAJAL, Professor, Hôpital Armand TrousseauPrincipal Investigator

Lead Sponsor

Hôpital Armand TrousseauOTHER

Collaborators

Name	Class
Hopital Universitaire Robert-Debre	OTHER
Hôpital Jean Verdier	OTHER
Centre Hospitalier Intercommunal Creteil	OTHER
Versailles Hospital

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

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.

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

No data available

No data is available for this block.

Enrollment

1,200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacterial meningitis	Results of lumbar puncture or meningitis history in charts	7 days after emergency visit
Herpes simplex virus meningitis/encephalitis	Results of lumbar puncture or meningitis history in charts	7 days after emergency visit

Secondary Outcomes

Measure	Description	Time Frame
emergent intracranial processus		7 days after emergency visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

febrile (>38°)
Seizure

Exclusion Criteria:

previous non febrile seizure
known trauma
immunodeficiancy status
Underlying illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

This was a retrospective cohort review of consecutive patients admitted in 7 pediatric emergency departments in Ile-de-France between 2007 and 2011. All clinically well-apparent children 3 to 11 months of age with a first simple febrile seizure were included in the study. All children between 3 months and 5 years with a complex febrile seizure were included

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo Carbajal, MD, PhD	Hôpital Armand Trousseau, Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Jean Verdier		Bondy		93140	France
Centre hospitalier intercommunal de creteil

Condition Browse Module

MeSH Terms

ID	Term
D012640	Seizures
D003294	Seizures, Febrile
D008581	Meningitis
D004660	Encephalitis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided