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Right Dose, Right Now: Model Validation

Right Dose, Right Now: Model Validation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21977
Enrollment
500
Registered
2017-08-25
Start date
2017-06-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Pharmacometrics Prediction Sepsis Infectious disease Personalized medicine Antibiotics Antibiotica Farmacometrie Infectieziekten Predictiemodellen

Interventions

For the prospective part of the study we will take an average of six blood samples per patient, per antibiotic/antimycotic.

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For the prospective part of this study, the inclusion criteria are: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age ≥ 18 years - The patient is receiving antibiotics and/or antimycotic agents to treat an infectious disease. For the retrospective part of this study the inclusion criteria are: - The patient has been treated on the Intensive Care unit of the VUmc or OLVG Oost and the patient data has been stored in an electronic patient file (in OLVG from 1999 and VUmc from 2003) - There is at least 1 relevant pharmacometric outcome measure available (e.g. vancomycine plasma concentration)

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
• Agreement between predicted and observed relevant pharmacometric parameters using Bland-Altman analysis • Percentage of correct first predictions of each pharmacometric model. • Extent to which all relevant pharmacometric goals are being met.

Contacts

Public ContactB. van Dijk
b.vandijk@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)