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MeningitisATLAS-IINCT07062445

Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis

An observational study of Meningitis and Bacterial Infections, run by Hospital Israelita Albert Einstein at 1 site 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 pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age with suspected acute infectious meningitis. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Meningitis, Bacterial Infections, Viral Meningitis
How many people
600 participants
Where
1 siteBrazil
Study dates
29 Mar 2026to Feb 2027
How long will I take part?
180 Days
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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric population, <17 years old, suspect of acute meningitis infection

Who may be able to join

  • 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
  • In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle.

Who cannot join

  • Refusal to provide consent for study participation

Trial locations and contacts

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

Anna M Gomes contact

+55 11 2151-1233 ext. 75915

anna.gomes@einstein.br

Brazil1 site, 1 recruiting

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05653-000

    Lucas F Theotonio dos Santos, PhD, +5511942057907, lucas.theotonio@einstein.br

    Henrique A R Fonseca, PhD

    Recruiting

Other trials in Brazil

About this study

Prospective, multicenter, observational clinical registry of pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age 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 will be performed at 28, 90 and 180 days after inclusion in the study.

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 (PNI), neurological sequelae and access to specialized rehabilitation services post-discharge.

Primary outcomes will be all-cause mortality, length of hospital stay, rate of re-hospitalization and sensorineural hearing loss incidence.

Secondary outcomes will be etiology-specific mortality, functional outcomes (PCPC-BR and pediatric FSS - Brazilian version), guideline-based therapies by etiology, neurological sequelae incidence stratified by etiology (e.g., motor deficits, cerebrovascular complications) , serious adverse events and access to rehabilitation.

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

Keywords
meningitis, bacterial, virus, corticosteroids, antibiotics, fungal
Medical subject headings
Meningitis, Bacterial Infections, Meningitis, Viral, Meningitis, Fungal, Virus Diseases

What is being measured

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

  1. Mortality, re-hospitalization, length of hospital stay and sensory hearing loss

    The primary outcome is a composite endpoint and for that a hierarchical statistical analysis of the components will be applied, considering their clinical importance and the temporal relevance between events (mortality will take precedence over the other components: incidence of all-cause re-hospitalization, length of initial hospital stay -measured in days and incidence of sensory hearing loss). The statistical methodology will include the use of the hierarchical Win Ratio and/or equivalent approaches.

    Measured: Day 28

Secondary outcomes (12)

  1. Patients with guideline-directed therapy

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

    Measured: Day 180

  2. Mortality in six months

    Incidence of all-cause mortality

    Measured: Day 180

  3. Rate of re-hospitalization

    Incidence of all-cause re-hospitalization

    Measured: Day 180

  4. Invasive ventilatory support

    Incidence of invasive ventilatory support

    Measured: Day 28

  5. Access to specialized rehabilitation services post-discharge

    Proportion of patients receiving specialized rehabilitation care

    Measured: Day 28, day 90 and day 180

  6. Length of hospitalization by etiology

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

    Measured: Day 180

  7. Re-hospitalization rate by etiology

    Rate of unplanned re-hospitalization stratified by etiology

    Measured: Day 180

  8. Neurological sequelae by etiology

    Incidence of neurological sequelae stratified by etiology

    Measured: Day 180

  9. Post-discharge functional neurological decline

    Neurological Functional Status will be assessed using Brazilian version of the Functional Status Scale (FSS-BR):

    • No disability: FSS= 6
    • Mild disability: FSS= 7-9
    • Moderate disability: FSS= 10-15
    • Severe disability: FSS= 16-21
    • Very severe disability: FSS>21

    Measured: Day 28 and day 180

  10. Cerebral Performance Post-Meningitis

    Cerebral Performance Post-Meningitis will be assessed using PCPC-BR (Pediatric Cerebral Performance Category - Brazilian version).

    For the purpose of this analysis, cases with a score of 6 (brain death) will be excluded here, as they will be accounted separately in the mortality outcome.

    • No disability: PCPC= 1
    • Mild disability: PCPC= 2
    • Moderate disability: PCPC= 3
    • Severe disability: PCPC= 4
    • Very severe disability: PCPC=5

    Measured: Day 28 and day 180

  11. Adverse Events

    Incidence of adverse events

    Measured: Day 28

  12. Adverse outcomes by etiology

    Incidence of adverse outcomes by etiology

    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 posted14 Jul 2025
  2. Study start29 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
600 participants (estimated)
Target duration
180 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07062445
Sponsor's protocol ID
ATLAS-II
Acronym
ATLAS-II
Status last verified
Jun 2025
First submitted
29 May 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
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 Meningitis and Bacterial Infections, run by Hospital Israelita Albert Einstein at 1 site 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 4 inclusion and 1 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Anna M Gomes (+55 11 2151-1233 ext. 75915, anna.gomes@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality, re-hospitalization, length of hospital stay and sensory hearing loss (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 NCT07062445.

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 May 2026.

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