Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil
IMPACTO-SNC
1 other identifier
observational
554
1 country
18
Brief Summary
Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMay 14, 2024
May 1, 2024
1.3 years
August 11, 2022
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence density of central nervous system infection
Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.
30 days after study inclusion
Secondary Outcomes (6)
Microbiological characteristics
30 days after study inclusion
Risk factors
30 days after study inclusion
Treatment
30 days after study inclusion
Costs
30 days after study inclusion
Deaths
30 days and 6 months after study inclusion
- +1 more secondary outcomes
Eligibility Criteria
Adults admitted to Intensive Care Units.
You may qualify if:
- All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt.
You may not qualify if:
- Diagnosis of brain death.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unimed Vitória
Vitória, Espírito Santo, Brazil
Hospital Geral Cleriston Andrade
Feira de Santana, Estado de Bahia, Brazil
Hospital da Cidade
Salvador, Estado de Bahia, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Santa Casa de Misericórdia de São João del Rei
São João del Rei, Minas Gerais, Brazil
Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
Florianópolis, Santa Catarina, Brazil
Hospital de Amor (Fundação PIO XII - Barretos)
Barretos, São Paulo, Brazil
Hospital Unimed Limeira
Limeira, São Paulo, Brazil
Hospital das Clínicas - FMUSP Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital e Maternidade Brasil (Rede D´or São Luis)
Santo André, São Paulo, Brazil
Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Hospital do Coração
São Paulo, São Paulo, Brazil
Hospital São Luiz Itaim
São Paulo, São Paulo, Brazil
Hospital São Paulo
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viviane Veiga, PhD
Beneficencia Portuguesa Sao Paulo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2022
First Posted
May 14, 2024
Study Start
August 15, 2022
Primary Completion
December 1, 2023
Study Completion
June 30, 2024
Last Updated
May 14, 2024
Record last verified: 2024-05