Status:

RECRUITING

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

Lead Sponsor:

Poznan University of Medical Sciences

Collaborating Sponsors:

University at Buffalo

The Greater Poland Cancer Centre

Conditions:

Population Modeling of Anti-infective Drugs

Eligibility:

All Genders

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, conc...

Detailed Description

Cefotaxime and meropenem are broad-spectrum antibiotics, most commonly prescribed in pediatric and adult intensive care units. Unfortunately, the applied dosing regimens based on the results obtained ...

Eligibility Criteria

Inclusion

  • Obtaining informed consent from the patient/parent of the patient
  • A bacterial and fungal infection that requires the use of at least one of the drugs listed based on clinical indications and the attending physician's decision.

Exclusion

  • Proven allergic reaction to medications used
  • No written consent
  • Contraindications in SmPC
  • Combination therapy with at least two antibacterial drugs and/or at least two antifungal drugs

Key Trial Info

Start Date :

October 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2025

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT05426499

Start Date

October 1 2021

End Date

September 30 2025

Last Update

May 31 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Greater Poland Voivodeship, Poland, 60-572

2

Poznan University of Medical Sciences, Department of Clinical Pharmacy and Biopharmacy

Poznan, Greater Poland Voivodeship, Poland, 60-806

3

Szpital Kliniczny im. Heliodora Święcickiego UMP

Poznan, Greater Poland Voivodeship, Poland, 61-848

4

Wielkopolskie Centrum Onkologii

Poznan, Greater Poland Voivodeship, Poland, 61-866