SeizureNCT01694524
Nervous System Infections Among Patients With Febrile Seizure
An observational study of Seizure and Febrile Seizure, run by Hôpital Armand Trousseau at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Seizure, Febrile Seizure, Meningitis
- How many people
- 1,200 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- febrile (>38°)
- Seizure
Who cannot join
- previous non febrile seizure
- known trauma
- immunodeficiancy status
- Underlying illness
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hopital Jean Verdier
Bondy, 93140
Centre hospitalier intercommunal de creteil
Créteil, 94010
Centre hospitalier Lagny-Marne la Vallée
Lagny-sur-Marne, 77405
Centre hospitalier de Versailles
Le Chesnay, 78157
Hôpital Armand Trousseau
Paris, 75012
Hopital Robert Debré
Paris, 75019
Centre hospitalier intercommunal de Poissy
Poissy, 78300
About this study
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
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.
- Conditions
- Seizure, Febrile Seizure, Meningitis, Encephalitis
- Medical subject headings
- Seizures, Seizures, Febrile, Meningitis, Encephalitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial meningitis
Results of lumbar puncture or meningitis history in charts
Measured: 7 days after emergency visit
Herpes simplex virus meningitis/encephalitis
Results of lumbar puncture or meningitis history in charts
Measured: 7 days after emergency visit
Secondary outcomes (1)
emergent intracranial processus
Measured: 7 days after emergency visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, Hôpital Jean Verdier, Centre Hospitalier Intercommunal Creteil, Versailles Hospital, Centre hospitalier Lagny Marne la vallée, Centre hospitalier intercommunal de Poissy
- Responsible party
- Principal investigator, CARBAJAL, Hôpital Armand Trousseau
- Investigators
- Ricardo Carbajal, MD, PhD, Principal investigator, Hôpital Armand Trousseau, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694524
- Sponsor's protocol ID
- febrile seizure and infection
- Status last verified
- May 2014
- First submitted
- 24 Sep 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01694524
- Acronym / sponsor ID
- febrile seizure and infection
- Conditions
- Seizure, Febrile Seizure, Meningitis, Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, Hôpital Jean Verdier, Centre Hospitalier Intercommunal Creteil, Versailles Hospital, Centre hospitalier Lagny Marne la vallée, Centre hospitalier intercommunal de Poissy
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- febrile (>38°)
- Seizure
Key exclusion criteria (4 listed)
- previous non febrile seizure
- known trauma
- immunodeficiancy status
- Underlying illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial meningitis
Time frame: 7 days after emergency visit
Results of lumbar puncture or meningitis history in charts
Herpes simplex virus meningitis/encephalitis
Time frame: 7 days after emergency visit
Results of lumbar puncture or meningitis history in charts
1 secondary outcome
emergent intracranial processus
Time frame: 7 days after emergency visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Carbajal, MD, PhD principal investigator
Hôpital Armand Trousseau, Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure and Febrile Seizure, run by Hôpital Armand Trousseau at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial meningitis (time frame: 7 days after emergency visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.