Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach

1 country

4 active sites

Status

recruiting

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

4 years study duration

Study Start

First participant enrolled

October 1, 2021

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed

6 months until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed

Last Updated

May 31, 2025

Status Verified

June 1, 2024

Enrollment Period

3.7 years

First QC Date

December 17, 2021

Last Update Submit

May 27, 2025

Conditions

Population Modeling of Anti-infective Drugs

Keywords

Population modelingPediatric UnitsPharmacokineticsPharmacodynamicsAnti-infective drugsCefotaximeMeropenemeFluconazoleIsavuconazoleAnidulafingin

Outcome Measures

Primary Outcomes (5)

Cefotaxime plasma concentration [ng/ml]
Measurements of cefotaxime plasma concentrations \[ng/ml\] before and after dosage of a drug. Blood samples were collected according to the study protocol.
Just before the next dose and at 0.33; 0.66; 1; 2; 4; 6; 8 hours after the start of drug administration
Meropenem plasma concentration [ng/ml]
Measurements of meropenem plasma concentrations \[ng/ml\] before and after dosage of a drug. Blood samples were collected according to the study protocol.
Just before the next dose and at 1,5; 3; 6; 8 hours after the start of drug administration
Fluconazole plasma concentration [ng/ml]
Measurements of fluconazole plasma concentrations \[ng/ml\] before and after dosage of a drug. Blood samples were collected according to the study protocol.
Just before the next dose and at 0,5; 1; 3; 10; 24 hours after the start of drug administration
Isavuconazole plasma concentration [ng/ml]
Measurements of isavuconazole plasma concentrations \[ng/ml\] before and after dosage of a drug. Blood samples were collected according to the study protocol.
Just before the next dose and at 0,25; 0,5; 0,75; 1; 1,25; 1,5; 2; 3; 4; 6; 8; 10; 12; 14; 16; 24 hours after the start of drug administration
Anidulafungin plasma concentration [ng/ml]
Measurements of anidulafungin plasma concentrations \[ng/ml\] before and after dosage of a drug. Blood samples were collected according to the study protocol.
Just before the next dose and at 0,5; 1; 1,5; 2; 4; 6; 8; 10; 12; 24 hours after the start of drug administration