Health TrialsbyHealthPanel

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

ConditionsViral MeningitisBacterial MeningitisFungal MeningitisMeningitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Adult, ≥ 18 years old, suspect 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 that includes: Incidence of all-cause death Incidence of all-cause re-hospitalization Length of initial hospital stay (measured in days) Incidence of sensory hearing loss

Time frame
Day 28

Secondary outcomes

1

Patients with guideline-directed therapy

Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines

Time frame
Day 180
2

Mortality in six months

Incidence of all-cause mortality

Time frame
Day 180
3

Length of hospitalization by etiology

Length of hospitalization (in days), stratified by infectious etiology

Time frame
Day 180
4

Re-hospitalization rate

Rate of all-cause re-hospitalization

Time frame
Day 180

Other outcomes

Sponsors 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
Apply now