NCT07027475 Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
| NCT ID | NCT07027475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Viral Meningitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 624 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 624 participants in total. It began in 2026-03-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Henrique A Fonseca, PhD
STUDY CHAIR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT07027475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Viral Meningitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07027475 currently recruiting?
Yes, NCT07027475 is actively recruiting participants. Contact the research team at anna.gomes@einstein.br for enrollment information.
Where is the NCT07027475 trial being conducted?
This trial is being conducted at Fortaleza, Brazil, Passo Fundo, Brazil, Porto Alegre, Brazil, Ribeirão Preto, Brazil and 2 additional locations.
Who is sponsoring the NCT07027475 clinical trial?
NCT07027475 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Henrique A Fonseca, PhD at Hospital Israelita Albert Einstein. The trial plans to enroll 624 participants.