National Bacterial Meningitis Study

NCT04664569

Last updated date
Study Location
ACTIV
Créteil, , , France
Contact
0033148850404

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningitis, Only Children, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines, H. Influenzae Vaccine, Neonatal Infection, Antibiotic Treatment, Case Fatality Rate
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-18
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


-

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Meningitis, Only Children, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines, H. Influenzae Vaccine, Neonatal Infection, Antibiotic Treatment, Case Fatality RateNational Bacterial Meningitis Study
NCT04664569
  1. Créteil,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title National Bacterial Meningitis Study
Official Title Observatoire National Des méningites bactériennes de l'Enfant et du Nouveau-né
Brief 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. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population children 0 day to 18 years with bacterial meningitis or purpura fulminans
Condition
  • Meningitis
  • Children, Only
  • Pneumococcal Conjugate Vaccine
  • Meningococcal Vaccines
  • H. Influenzae Vaccine
  • Neonatal Infection
  • Antibiotic Treatment
  • Case Fatality Rate
Intervention Other: observational study
observational study
Study Groups/Cohorts Cohort of bacterial meningitis in children
Intervention: Other: observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 7, 2020)
7680
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2030
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

-

Sex/Gender
Sexes Eligible for Study:All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Corinne Levy, MD0033148850404[email protected]
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04664569
Other Study ID Numbers Obs meningite
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Association Clinique Thérapeutique Infantile du val de Marne
Study Sponsor Association Clinique Thérapeutique Infantile du val de Marne
Collaborators Pfizer
Investigators Not Provided
PRS Account Association Clinique Thérapeutique Infantile du val de Marne
Verification Date March 2021