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Vancomycin treatment optmization in neonatal and pediatric population using machine learning tools and statistical modeling

Vancomycin model-informed precision dosing and proposal of new PK-PD effectiveness indices through machine learning and statistical modeling in neonatal and pediatric populations

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-7pjwxp6
Enrollment
Unknown
Registered
2025-07-10
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Interventions

Retrospective study involving neonates, infants, children and adolescents, admitted to the Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Hospital
G03.787
E01.370.520.200

Sponsors

Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator
Hospital Universitário da Universidade de São Paulo
Collaborator
Hospital Municipal Infantil Menino Jesus
Collaborator

Eligibility

Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Neonatal and pediatric patients (0 to 18 years old); of both sexes; who received vancomycin and underwent therapeutic drug monitoring trough vancomycin serum concentration

Exclusion criteria

Exclusion criteria: Adults patients (18 years and above)

Design outcomes

Primary

MeasureTime frame
It is expected to determine a vancomycin pharmacokinetic-pharmacodynamic effectiveness index associated to lower mortality of all-causes, through CART (classification and regression tree) and propensity score analysis;It is expected to determine a vancomycin pharmacokinetic-pharmacodynamic effectiveness index associated to better complete and/or partial clinical response and lower therapeutic failure, through CART (classification and regression tree) and propensity score analysis—

Secondary

MeasureTime frame
It is expected to determine a vancomycin pharmacokinetic-pharmacodynamic effectiveness index associated to shorter hospital and ICU length of stay, through CART (classification and regression tree) and propensity score analysis;It is expected to determine a vancomycin pharmacokinetic-pharmacodynamic effectiveness index associated to longer antimicrobial free survival, through CART (classification and regression tree) and propensity score analysis;It is expected to determine a vancomycin pharmacokinetic-pharmacodynamic effectiveness index associated to shorter time to microbiologic cure, clinical cure and/or complete clinical response, through CART (classification and regression tree) and propensity score analysis—

Countries

Brazil

Contacts

Public ContactVictor Kaneko Matsuno

Faculdade de Ciências Farmacêuticas da Universidade de São Paulo

victor.matsuno@gmail.com+55(11)30912189

Outcome results

None listed

Source: REBEC (via WHO ICTRP)