Actively Recruiting
Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
Led by Hospital Israelita Albert Einstein · Updated on 2026-05-05
600
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hospital Israelita Albert Einstein
Lead Sponsor
M
Ministry of Health, Brazil
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter observational clinical registry involving pediatric patients under 18 years old who have suspected acute infectious meningitis in about 20 public and private hospitals across Brazil. The study aims to collect real-world data on current clinical management, treatment, and both short- and long-term outcomes to help improve national care protocols. It focuses on gathering evidence about acute infectious meningitis caused by bacterial, viral, or fungal infections. During hospitalization, clinical and laboratory data will be collected, including timing and type of antibiotic therapy, corticosteroid use, vaccination status, and neurological complications. Follow-up visits will occur at 28, 90, and 180 days after enrollment to assess outcomes such as mortality, length of hospital stay, re-hospitalization rates, hearing loss, neurological sequelae, and access to specialized rehabilitation services. The study will observe how treatments align with guidelines and record adverse events. Participants will be monitored through hospital data collection during their stay and follow-up appointments after discharge. Evaluations include functional neurological outcomes using pediatric scales, assessments of motor and cerebrovascular complications, and recording serious adverse events. The primary outcomes measured are mortality, re-hospitalization, hospital stay duration, and sensorineural hearing loss at day 28. Secondary outcomes involve longer-term mortality, rehabilitation access, and functional declines up to 180 days. The study runs until February 2027, aiming to inform pediatric care and public health policies in Brazil.
CONDITIONS
Brief Title
Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under 18 years of age with suspected acute infectious meningitis
- Fever (axillary temperature 6578.8�b0C) with two or more symptoms: severe headache, vomiting, altered consciousness, photophobia, or seizures
- Fever accompanied by at least one meningeal irritation sign such as neck stiffness, Kernig's sign, or Brudzinski's sign
- Sudden fever onset with petechial skin rash or hemorrhagic spots
- For children under two years, fever with irritability, persistent crying, somnolence, or bulging fontanelle
You will not qualify if you...
- Refusal to provide consent for study participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of hospital stay
Participants are observed during hospitalization with collection of clinical and laboratory data including timing and type of antibiotic therapy, corticosteroid initiation, vaccination status, and neurological outcomes.
Data collected during hospitalization
Duration - Up to 6 months after hospital discharge
Participants attend follow-up visits after hospital discharge to assess mortality, rehospitalization, neurological sequelae, functional outcomes, and access to rehabilitation services.
Follow-up visits at 28, 90, and 180 days after inclusion
Trial Site Locations
Total: 1 location
1
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05653-000
Actively Recruiting
Research Team
A
Anna M Gomes
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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