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Viral MeningitisATLAS-INCT07027475

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

An observational study of Viral Meningitis and Bacterial Meningitis, run by Hospital Israelita Albert Einstein at 6 sites in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
624 participants
Where
6 sitesBrazil
Study dates
30 Mar 2026to Feb 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult, ≥ 18 years old, suspect acute meningitis infection

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lucas F Theotonio dos Santos, PhD contact

+55 11 2151-1233

lucas.theotonio@einstein.br

6 sites in 1 country

Brazil6 sites, 5 recruiting

  • Hospital Universitário Walter Cantídio

    Fortaleza, Ceará

    Active, not recruiting

  • Hospital São Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

    Aloma S Menegasso, Clinical Research Coordinator, +5554992216669, farmaloma@hsvp.com.br

    Alexandre P Tognon, MD, PhD

    Recruiting

  • Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-032

    Giovanna Antunes, +55 51 33143209, regulatorio.pesquisa@hmv.org.br

    Thais L Secchi, MD, MSc, +55 51 998977789, contato.pesquisaclinica@hmv.org.br

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

    Ribeirão Preto, São Paulo, 14051-140

    Silvia F B M Negrini, Clinical Research Coordinator, +5516981349907, sissinegrini@gmail.com

    Rodrigo C Santana, MD, PhD

    Recruiting

  • Hospital Municipal Dr Moysés Deutsch - M'Boi Mirim

    São Paulo, São Paulo, 04905020

    RAFAELA A ALQUERES, MD, +5511961947957

    Edmilson Carvalho, +5511984777507, edmilson.carvalho@einstein.br

    Recruiting

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-070

    Carlos E Opazo, Clinical Research Coordinator, +5511985986136, carlos.opazocpc@santamarcelina.org

    Vanessa L da Costa, MD

    Recruiting

Other trials in Brazil

About this study

Official title: Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis

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.

Read the detailed description

This is a middle-income real-world prospective clinical registry study. Clinical and laboratory data will be collected during hospitalization and follow-up visits after discharge.

Data collection will include empirical antibiotic therapy timing and type, time from hospital admission to antibiotic's first dose, corticosteroid therapy initiation, vaccination status per the Brazilian National Immunization Program, neurological sequelae and access to specialized rehabilitation services post-discharge.

Primary outcome will be all-cause mortality. Secondary outcomes will be length of hospital stay, rate of re- hospitalization, sensorineural hearing loss incidence, etiology-specific mortality, functional outcomes (measured by modified Rankin Score and Barthel Index Brazilian version), guideline-based therapies by etiology, neurological sequelae incidence stratified by etiology (e.g., motor deficits, cerebrovascular complications), adverse events, incidence of use of post-meningitis assistive devices and access to rehabilitation.

Findings will be used to inform public health system and clinical care in Brazil.

Keywords
Meningitis, Bacterial, Viral, Corticosteroids, Antibiotics, Fungal
Medical subject headings
Meningitis, Viral, Meningitis, Bacterial, Meningitis, Fungal, Meningitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    The primary outcome is the incidence of all-cause death

    Measured: Day 28

Secondary outcomes (16)

  1. Re-hospitalization

    Incidence of all-cause re-hospitalization

    Measured: Day 28

  2. Length of hospital stay

    Length of initial hospital stay (measured in days)

    Measured: Day 28

  3. Invasive ventilatory support

    Incidence of invasive ventilatory support

    Measured: Day 28

  4. Adverse Events

    Incidence of adverse events

    Measured: Day 28

  5. First dose of antibiotic therapy

    Time from hospital admission to administration of the first dose of antibiotic therapy

    Measured: Day 28

  6. Sensory hearing loss

    Incidence of sensory hearing loss

    Measured: Day 28

  7. Patients with guideline-directed therapy

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

    Measured: Day 180

  8. Mortality in six months

    Incidence of all-cause mortality

    Measured: Day 180

  9. Length of hospitalization by etiology

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

    Measured: Day 180

  10. Re-hospitalization rate

    Rate of all-cause re-hospitalization

    Measured: Day 180

  11. Access to specialized rehabilitation services

    Proportion of patients receiving specialized rehabilitation care

    Measured: Day 180

  12. Re-hospitalization rate by etiology

    Rate of unplanned re-hospitalization stratified by etiology

    Measured: Day 180

  13. Neurological sequelae by etiology

    Incidence of neurological sequelae stratified by etiology

    Measured: Day 180

  14. Post-discharge functional decline

    Functional status decline assessed on follow-up using Functional independence measured by modified Rankin Score ≤ 2 and Barthel Index (Brazilian version)

    Functional status will be assessed using two standardized measures: the Modified Rankin Score (mRS) and the Barthel Index (Brazilian version). Decline in functional independence will be categorized as follows:

    • Mild disability: defined by an mRS score of 0 to 2 and a Barthel Index score of 90 or higher, indicating independence or slight dependence in daily activities.
    • Moderate disability: defined by an mRS score of 3 and a Barthel Index score between 60 and 89, corresponding to moderate dependence requiring some assistance.
    • Severe disability: defined by an mRS score of 4-5 and a Barthel Index score below 60, reflecting severe dependence or bedridden status with the need for constant care.

    Measured: Day 180

  15. Adverse outcomes requiring secondary intervention by etiology

    Incidence of adverse outcomes by etiology

    Measured: Day 180

  16. Post-meningitis assistive devices

    Incidence of use of post-meningitis assistive devices (hearing aid; ambulation support - wheelchair, walker; nasoenteral tube or gastrostomy; ventilatory support; limb prosthesis; low-vision assistive device; cerebrospinal fluid shunt device);

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start30 Mar 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
624 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07027475
Sponsor's protocol ID
ATLAS-I
Acronym
ATLAS-I
Status last verified
May 2026
First submitted
3 Jun 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Viral Meningitis and Bacterial Meningitis, run by Hospital Israelita Albert Einstein at 6 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucas F Theotonio dos Santos, PhD (+55 11 2151-1233, lucas.theotonio@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07027475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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