Modeling how common antibiotics and antifungals act and are processed in children and adults
Translational PKPD Modeling of Anti-infective Drugs in Children Treated in Pediatric Units on the Example of Selected Antibiotics and Antifungals.
This project will test population PK/PD models to predict how cefotaxime, meropenem, fluconazole, isavuconazole, and anidulafungin are handled and work in children and adults who need these drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 4 sites (Poznan, Greater Poland Voivodeship and 3 other locations) |
| Trial ID | NCT05426499 on ClinicalTrials.gov |
What this trial studies
This observational project will collect timed blood samples from about 150 children and adults receiving cefotaxime, meropenem, fluconazole, isavuconazole, or anidulafungin at participating Poznań hospitals. Researchers will measure drug concentrations and microbiological effect (MIC) and build mechanistic PK/PD population models using indices such as T>MIC, Cmax/MIC, and AUC/MIC. Covariates that may alter pharmacokinetics or pharmacodynamics (age, weight, organ function, drug interactions) will be recorded and incorporated into the models. The goal is to generate dosing recommendations that better reflect pediatric and adult variability without altering routine clinical care.
Who should consider this trial
Good fit: Ideal candidates are children or adults with a confirmed bacterial or fungal infection who require one of the listed drugs and can provide informed consent (or have parental consent).
Not a fit: Patients already receiving combination therapy with two or more antibacterial or antifungal drugs, those with contraindications or proven allergies to the study drugs, or those unwilling to consent will not be enrolled and therefore will not benefit from this project.
Why it matters
Potential benefit: If successful, the models could help personalize dosing to improve effectiveness and reduce toxicity of these anti-infective drugs, especially in children.
How similar studies have performed: Population PK/PD modeling has produced useful dosing guidance in adults, but comparable pediatric data are scarce and this project aims to fill that gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Poznan, Greater Poland Voivodeship and 3 other locations
- Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu — Poznan, Greater Poland Voivodeship, Poland (Recruiting)
- Poznan University of Medical Sciences, Department of Clinical Pharmacy and Biopharmacy — Poznan, Greater Poland Voivodeship, Poland (Active_not_recruiting)
- Szpital Kliniczny im. Heliodora Święcickiego UMP — Poznan, Greater Poland Voivodeship, Poland (Not_yet_recruiting)
- Wielkopolskie Centrum Onkologii — Poznan, Greater Poland Voivodeship, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Agnieszka Bienert, MSC,PhD — Poznań University of Medical Sciences
- Study coordinator: Agnieszka Bienert, MSC, PhD
- Email: agbienert@op.pl
- Phone: +48616687844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.