Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.

Summary

Pharmacokinetic and pharmacodynamic modeling (PKPD) is becoming an essential tool for optimizing pharmacotherapy. Building mechanistic models allows determining the relationship between the dose, concentration, pharmacological effect, and side effects in various populations. The growing resistance to drugs among bacteria is a challenge for medicine, and the progress in pharmacometrics enables us to make rational clinical decisions. A particular group of patients is children with differences in PK and PD of drugs. The lack of clinical studies often forces to extrapolate dosing based on the results obtained in adults. In intensive care units, up to 70-90% of drugs in children are used off-label. Drug agencies point to the importance of the population-based approach to data analysis, especially in infants and children. Under the project, work will focus on the PK and PD of antifungal drugs (fluconazole, isavuconazole, and anidulafungin) and antibiotics (cefotaxime and meropenem) in the pediatric and adult populations. The choice of topic is dictated by the growing need to create PKPD models of the drugs mentioned above in children. The hypothesis is the assumption that using a mathematical model will enable to describe the time course of the drug in the organism, the relationship between the effect and the dose of the medicine and its concentration in the plasma, and the influence of individual factors on the PKPD profile of a drug.

Conditions

• Population Modeling of Anti-infective Drugs

Interventions

DRUG

Patients requiring cefotaxime treatment

Dosage according to SmPC

DRUG

Patients requiring meropenem treatment

Dosage according to SmPC

DRUG

Patients requiring fluconazole treatment

Dosage according to SmPC

DRUG

Patients requiring isavuconazole treatment

Dosage according to SmPC

DRUG

Patients requiring anidulafungin treatment

Dosage according to SmPC

Sponsors & Collaborators

• University at Buffalo

  collaborator OTHER

• The Greater Poland Cancer Centre

  collaborator OTHER

• Poznan University of Medical Sciences

  lead OTHER

Principal Investigators

• Agnieszka Bienert, MSC,PhD · Poznań University of Medical Sciences

• Alicja Bartkowska-Śniatkowska, MD, PhD · Poznań University of Medical Sciences

• Edmund Grześkowiak, MSC, PhD · Poznań University of Medical Sciences

• William J. Jusko, PhD · School of Pharmacy and Pharmaceutical Sciences, Department of Pharmaceutical Sciences

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2025-06-30

Completion

2025-09-30

Countries

• Poland

Study Locations