- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664569
National Bacterial Meningitis Study
December 22, 2022 updated by: Association Clinique Thérapeutique Infantile du val de Marne
National Observatory of Bacterial Meningitis in Children and Newborns
Bacterial meningitis is a major cause of morbidity and mortality in childhood.
Antibiotic treatment recommendations are based on epidemiological and susceptibility data.
The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines.
The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
8230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Corinne Levy, MD
- Phone Number: 0033148850404
- Email: corinne.levy@activ-france.fr
Study Locations
-
-
-
Créteil, France
- Recruiting
- ACTIV
-
Contact:
- Corinne Levy, MD
- Phone Number: 0033148850404
- Email: corinne.levy@activ-france.fr
-
Contact:
- Stéphane Béchet, MSc
- Phone Number: 0033148850404
- Email: stephane.bechet@activ-france.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children 0 day to 18 years with bacterial meningitis or purpura fulminans
Description
Inclusion Criteria:
- clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (> 10 cells/µL).
- purpura fulminans
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort of bacterial meningitis in children
|
observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: before the hospital discharge
|
Number of death according to age and bacteria
|
before the hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
treatment failures
Time Frame: 48 hours after the antibiotic treatment and new lumbar puncture
|
Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture
|
48 hours after the antibiotic treatment and new lumbar puncture
|
impact of vaccines
Time Frame: before the hospital discharge
|
Number of vaccination failures according to age, number of doses and bacteria
|
before the hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- Recurrent Pneumococcal Meningitis in Children: A Multicenter Case-control Study
- Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national survey
- Clinical and Laboratory Features of Group B Streptococcus Meningitis in Infants and Newborns: Study of 848 Cases in France, 2001-2014
- Risk Factors in Children Older Than 5 Years With Pneumococcal Meningitis: Data From a National Network
- Neonatal Meningococcal Meningitis In France From 2001 To 2013
- Comparative impact of pneumococcal conjugate vaccines on pneumococcal meningitis according to underlying conditions
- Outcomes of bacterial meningitis in children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2001
Primary Completion (Anticipated)
January 1, 2030
Study Completion (Anticipated)
January 1, 2030
Study Registration Dates
First Submitted
December 7, 2020
First Submitted That Met QC Criteria
December 7, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
December 27, 2022
Last Update Submitted That Met QC Criteria
December 22, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Obs meningitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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