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Recruiting
NCT07027475
Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Conditions: Viral Meningitis, Bacterial Meningitis, Fungal Meningitis, Meningitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 624
Sponsor: Hospital Israelita Albert Einstein
Location: Hospital Universitário Walter Cantídio Fortaleza Ceará
Summary
Prospective, multicenter, observational clinical registry of adult patients with acute infectious meningitis across approximately 30 public and private hospitals in Brazil. The study will include adults, 18 years old and older, 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
Inclusion Criteria:
Both sexes, aged ≥ 18 years, meeting one or more of the criteria (A, B or C) below:
--\> Criterion A: Clinical presentation compatible with a suspected case of meningitis or meningococcal disease:
Fever ≥ 37.8 °C (axillary) associated with at least two of the following:
* Severe headache
* Vomiting
* Altered level of consciousness (confusion, drowsiness, irritability)
* Photophobia
* Seizure OR Fever associated with one of the classic signs of meningeal irritation (neck stiffness, Kernig or Brudzinski signs) OR Sudden-onset fever with petechial rash or hemorrhagic suffusions
* Criterion B: Cerebrospinal fluid with leukocytes ≥ 5 cells/mm³ (corrected for red blood cell count at 1:500)
* Criterion C: Confirmed etiological diagnosis of meningitis or meningococcal disease with no more than 48 hours between pathogen confirmation and signature of the informed consent form by the participant or legal representative.
Exclusion criteria
* Refusal to provide consent for the study.
* Presence of a neurological condition, other than meningitis, that accounts for the current clinical picture.
* Clinical, laboratory or radiological evidence of an alternative infectious focus that accounts for the current clinical picture.
* Use of an intraventricular device prior to study inclusion.
* Etiological diagnosis of meningitis or meningococcal disease confirmed more than 48 hours earlier.
Source: ClinicalTrials.gov (NCT07027475). StuddyBuddy aggregates publicly available trial information.