MeningitisNCT04664569
National Bacterial Meningitis Study in Children and Newborns
An observational study of Meningitis and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Meningitis, Children, Only, Pneumococcal Conjugate Vaccine
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2001to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children 0 day to 18 years with bacterial meningitis or purpura fulminans
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: 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.
Read the detailed description
For children under 18, hospitalized for bacterial meningitis, the following data will be analyzed: risk factors, vaccination status, signs of symptoms, treatment during hospitalization, analysis (cerebrospinal fluid culture, cerebrospinal fluid antigen test, blood culture...), symptoms or clinic signs of illness.
- Conditions
- Meningitis, Children, Only, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines, H. Influenzae Vaccine, Neonatal Infection
- Medical subject headings
- Meningitis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Number of death according to age and bacteria
Measured: before the hospital discharge
Secondary outcomes (2)
treatment failures
Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture
Measured: 48 hours after the antibiotic treatment and new lumbar puncture
impact of vaccines
Number of vaccination failures according to age, number of doses and bacteria
Measured: before the hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2001
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MeningitisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Corinne Levy, MD, Study director, Association Clinique Thérapeutique Infantile du val de MarneRobert Cohen, Principal investigator, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664569
- Sponsor's protocol ID
- Obs meningitis
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maunier L, Levy C, Baron A, Weill FX, Bechet S, Pardos de la Gandara M, Caseris M, Abdoul C, Dommergues MA, Cohen R, Bonacorsi S. Retrospective Description of 27 Cases of Nontyphoidal Salmonella Meningitis in Pediatrics Over 22 Years in France Pleads for a Revision of Age Limit for the Treatment of Salmonella Gastroenteritis in Children. Pediatr Infect Dis J. 2026 Jan 1;45(1):e10-e12. doi: 10.1097/INF.0000000000004966. Epub 2025 Sep 3.
PubMed 40924727Fafi I, Cohen R, Levy C, Varon E, Amor-Chelihi L, Benhaim P, Houlier M, Koehl B, De Montalembert M, Allali S, Gauthier A, Odievre MH, Gajdos V, Escoda S, Kamdem A, Costa G, Guillaumat C, Thuret I, Ouldali N, Gaschignard J, Carbonnelle E, De Pontual L, Pham LL. High Mortality Due to Pneumococcal Meningitis in Children With Sickle Cell Disease: A French Multicenter Observational Study From 2001 to 2021. Pediatr Infect Dis J. 2025 Jun 1;44(6):496-502. doi: 10.1097/INF.0000000000004755. Epub 2025 Mar 7.
PubMed 40063777Rybak A, Ouldali N, Varon E, Taha MK, Bonacorsi S, Bechet S, Angoulvant F, Cohen R, Levy C; French Pediatric Meningitis Network. Vaccine-preventable Pediatric Acute Bacterial Meningitis in France: A Time Series Analysis of a 19-Year Prospective National Surveillance Network. Pediatr Infect Dis J. 2024 Jan 1;43(1):74-83. doi: 10.1097/INF.0000000000004134. Epub 2023 Nov 13.
PubMed 38108805
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory of Bacterial Meningitis in Children and Newborns
- ClinicalTrials.gov ID
- NCT04664569
- Acronym / sponsor ID
- Obs meningitis
- Conditions
- Meningitis, Children, Only, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines, H. Influenzae Vaccine, Neonatal Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Dec 2020 (actual)
- 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.
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.
Detailed description
For children under 18, hospitalized for bacterial meningitis, the following data will be analyzed: risk factors, vaccination status, signs of symptoms, treatment during hospitalization, analysis (cerebrospinal fluid culture, cerebrospinal fluid antigen test, blood culture...), symptoms or clinic signs of illness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children 0 day to 18 years with bacterial meningitis or purpura fulminans
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
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
mortality
Time frame: before the hospital discharge
Number of death according to age and bacteria
2 secondary outcomes
treatment failures
Time frame: 48 hours after the antibiotic treatment and new lumbar puncture
impact of vaccines
Time frame: before the hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 40924727Maunier L, Levy C, Baron A, Weill FX, Bechet S, Pardos de la Gandara M, Caseris M, Abdoul C, Dommergues MA, Cohen R, Bonacorsi S. Retrospective Description of 27 Cases of Nontyphoidal Salmonella Meningitis in Pediatrics Over 22 Years in France Pleads for a Revision of Age Limit for the Treatment of Salmonella Gastroenteritis in Children. Pediatr Infect Dis J. 2026 Jan 1;45(1):e10-e12. doi: 10.1097/INF.0000000000004966. Epub 2025 Sep 3.
- Derived from this study: PubMed 40063777Fafi I, Cohen R, Levy C, Varon E, Amor-Chelihi L, Benhaim P, Houlier M, Koehl B, De Montalembert M, Allali S, Gauthier A, Odievre MH, Gajdos V, Escoda S, Kamdem A, Costa G, Guillaumat C, Thuret I, Ouldali N, Gaschignard J, Carbonnelle E, De Pontual L, Pham LL. High Mortality Due to Pneumococcal Meningitis in Children With Sickle Cell Disease: A French Multicenter Observational Study From 2001 to 2021. Pediatr Infect Dis J. 2025 Jun 1;44(6):496-502. doi: 10.1097/INF.0000000000004755. Epub 2025 Mar 7.
- Derived from this study: PubMed 38108805Rybak A, Ouldali N, Varon E, Taha MK, Bonacorsi S, Bechet S, Angoulvant F, Cohen R, Levy C; French Pediatric Meningitis Network. Vaccine-preventable Pediatric Acute Bacterial Meningitis in France: A Time Series Analysis of a 19-Year Prospective National Surveillance Network. Pediatr Infect Dis J. 2024 Jan 1;43(1):74-83. doi: 10.1097/INF.0000000000004134. Epub 2023 Nov 13.
- Recurrent Pneumococcal Meningitis in Children: A Multicenter Case-control StudyLink provided by the sponsor.
- Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national surveyLink provided by the sponsor.
- Clinical and Laboratory Features of Group B Streptococcus Meningitis in Infants and Newborns: Study of 848 Cases in France, 2001-2014Link provided by the sponsor.
- Risk Factors in Children Older Than 5 Years With Pneumococcal Meningitis: Data From a National NetworkLink provided by the sponsor.
- Neonatal Meningococcal Meningitis In France From 2001 To 2013Link provided by the sponsor.
- Comparative impact of pneumococcal conjugate vaccines on pneumococcal meningitis according to underlying conditionsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Corinne Levy, MD study director
Association Clinique Thérapeutique Infantile du val de Marne
Robert Cohen principal investigator
Association Clinique Thérapeutique Infantile du val de Marne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (0033148850404, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: before the hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664569, which also lists 3 linked publications.
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 28 Apr 2026.