Actively Recruiting

Age: 0 - 17Years
All Genders
ID07062445

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

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Refusal to provide consent for study participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

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

Long-term Monitoring

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

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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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