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Nervous System Infections Among Patients With Febrile Seizure

This study is not yet open for participant recruitment.
Verified September 2012 by Hôpital Armand Trousseau
Sponsor:
Collaborators:
Robert Debré Hospital
Hopital Jean Verdier
Centre Hospitalier Intercommunal Creteil
Centre hospitalier de versailles
Centre hospitalier Lagny Marne la vallée
Centre hospitalier intercommunal de Poissy
Information provided by (Responsible Party):
CARBAJAL, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT01694524
First received: September 24, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition
Seizure
Febrile Seizure
Meningitis
Encephalitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hôpital Armand Trousseau:

Primary Outcome Measures:
  • Bacterial meningitis [ Time Frame: 7 days after emergency visit ] [ Designated as safety issue: No ]
    Results of lumbar puncture or meningitis history in charts

  • Herpes simplex virus meningitis/encephalitis [ Time Frame: 7 days after emergency visit ] [ Designated as safety issue: No ]
    Results of lumbar puncture or meningitis history in charts


Secondary Outcome Measures:
  • emergent intracranial processus [ Time Frame: 7 days after emergency visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • febrile (>38°)
  • Seizure

Exclusion Criteria:

  • previous non febrile seizure
  • known trauma
  • immunodeficiancy status
  • Underlying illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694524

Contacts
Contact: Ricardo Carbajal, MD, PhD 144736487 ext +33 ricardo.carbajal@trs.aphp.fr
Contact: Romain Guedj, MD 661757648 ext +33 romaingued@gmail.com

Locations
France
Hopital Jean Verdier
Bondy, France, 93140
Centre hospitalier intercommunal de creteil Not yet recruiting
Creteil, France, 94010
Contact: Sandra Biscardi, MD     145175414 ext +33     sandra.biscardi@chicreteil.fr    
Principal Investigator: Sandra Biscardi, MD            
Centre hospitalier Lagny-Marne la Vallée Not yet recruiting
Lagny-Sur-Marne, France, 77405
Contact: Gisèle Nissack-Obiketeki, MD     164307116 ext +33     gnissack@ch-lagny77.fr    
Principal Investigator: Gisèle Nissack, MD            
Centre hospitalier de Versailles Not yet recruiting
Le chesnay, France, 78157
Contact: Charara Oussama, MD     139639024 ext +33     ocharara@ch-versailles.fr    
Principal Investigator: Oussama Charara, MD            
Hôpital Armand Trousseau Not yet recruiting
Paris, France, 75012
Contact: Romain Guedj, MD     661757648 ext +33     romainguedj@gmail.com    
Principal Investigator: Romain Guedj, MD            
Hopital Robert Debré Not yet recruiting
Paris, France, 75019
Contact: Francois Angoulvant, MD     140032272 ext 33     francois.angoulvant@rdb.aphp.fr    
Principal Investigator: Francois Angoulvant, MD            
Sub-Investigator: Luigi Titomanlio, MD            
Centre hospitalier intercommunal de Poissy Not yet recruiting
Poissy, France, 78300
Contact: Béatrice Pellegrino, MD     139275591 ext +33     bpellegrino@chi-poissy-st-germain.fr    
Principal Investigator: Béatrice Pellegrino, MD            
Sponsors and Collaborators
Hôpital Armand Trousseau
Robert Debré Hospital
Hopital Jean Verdier
Centre Hospitalier Intercommunal Creteil
Centre hospitalier de versailles
Centre hospitalier Lagny Marne la vallée
Centre hospitalier intercommunal de Poissy
Investigators
Principal Investigator: Ricardo Carbajal, MD, PhD Hôpital Armand Trousseau, Paris
  More Information

No publications provided

Responsible Party: CARBAJAL, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT01694524     History of Changes
Other Study ID Numbers: febrile seizure and infection
Study First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Additional relevant MeSH terms:
Seizures, Febrile
Seizures
Encephalitis
Fever
Meningitis
Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Body Temperature Changes
Signs and Symptoms
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 16, 2013