Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorHospital Israelita Albert Einstein
About this trial
Prospective, multicenter, observational clinical registry of pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age with suspected acute infectious meningitis. Data will be collected during hospitalization and post-discharge to evaluate clinical management, treatment and short and long-term outcomes. The study aims to generate real-world evidence on current practices and outcomes to support improvements in national care protocols.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fever (axillary temperature ≥37.8°C) followed by two or more of the following symptoms*: severe headache, vomiting, altered consciousness (confusion, drowsiness, or irritability), photophobia (increased sensitivity to light), presence of seizures OR
Fever accompanied by at least one meningeal irritation sign, such as neck stiffness, Kernig's sign, or Brudzinski's sign OR
Sudden onset of fever and appearance of petechial skin rash or hemorrhagic suffusions
In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle.
Disqualifiers
Refusal to provide consent for study participation
Trial population
Pediatric population, \<17 years old, suspect of acute meningitis infection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
The primary outcome is a composite endpoint and for that a hierarchical statistical analysis of the components will be applied, considering their clinical importance and the temporal relevance between events (mortality will take precedence over the other components: incidence of all-cause re-hospitalization, length of initial hospital stay -measured in days and incidence of sensory hearing loss). The statistical methodology will include the use of the hierarchical Win Ratio and/or equivalent approaches.
Time frame
Day 28Secondary outcomes
1
Patients with guideline-directed therapy
Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines
Time frame
Day 1802
Mortality in six months
Incidence of all-cause mortality
Time frame
Day 1803
Rate of re-hospitalization
Incidence of all-cause re-hospitalization
Time frame
Day 1804
Invasive ventilatory support
Incidence of invasive ventilatory support
Time frame
Day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Israelita Albert Einstein
Lead sponsor
Ministry of Health, Brazil
Collaborator
Source ClinicalTrials.gov