Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
NCT07062445
Bacterial Infections, Bacterial Infections and Mycoses
São Paulo, Brazil
View Trial DetailsNCT Number: NCT07027475
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital São Vicente de Paulo, Passo Fundo, Rio Grande do Sul, Brazil
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 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 (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) , serious adverse events and access to rehabilitation.
Findings will be used to inform public health system and clinical care in Brazil.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 28
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 180
Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines
Time frame: Day 180
Incidence of all-cause mortality
Time frame: Day 180
Length of hospitalization (in days), stratified by infectious etiology
Time frame: Day 180
Rate of all-cause re-hospitalization
Time frame: Day 28
Incidence of invasive ventilatory support
Time frame: Day 180
Proportion of patients receiving specialized rehabilitation care
Time frame: Day 180
Rate of unplanned re-hospitalization stratified by etiology
Time frame: Day 180
Incidence of neurological sequelae stratified by etiology
Time frame: Day 180
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:
Time frame: Day 28
Incidence of adverse events
Time frame: Day 180
Incidence of adverse outcomes by etiology
Contact information is provided by the study sponsor or research team.
Hospital Israelita Albert Einstein
Other
Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis
Acronym: ATLAS-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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