Pharmacokinetics and Pharmacodynamics of Antimicrobials in Pediatric Patients

Dear Colleagues,

Based on the last report on child mortality released by the United Nations Children’s Fund (UNICEF) and the World Health Organization (WHO), infections are considered a leading cause of death in children under the age of 5 years and are estimated to cause over half of deaths in newborn and pediatric patients. Moreover, bacterial infections sustained by multidrug-resistant organisms are dramatically increasing and are responsible for a significant proportion of these deaths. As a consequence, in neonates and children, infections account for a high percentage of hospital admissions, and antimicrobials are the most used drugs.

However, due to the absence of pharmacokinetic/pharmacodynamic (PK/PD) studies involving pediatric patients and the lack of evidence regarding the efficacy and safety of some newly marketed antibiotics, these agents are usually used off-label in pediatrics. Additionally, optimal drug dosage regimens are poorly established in these patients and mainly based on “real-life” clinical practice.

It is also well known that, compared to adults, neonates and children are characterized by important differences in PK parameters such as drug clearance and volume of distribution. Therefore, these changes may alter antimicrobial disposition and expose patients to the risk of unsuccessful treatments. In addition, pediatric patients are more susceptible to potential adverse drug effects, and they need closer monitoring.

In this regard, therapeutic drug monitoring (TDM) represents a valid tool for the optimization of antimicrobial therapies and for the attainment of PK/PD targets of efficacy. In fact, TDM could be useful not only to increase the chances of therapeutic success but also to avoid the risk of toxicities and to prevent the selection of antimicrobial resistance, especially in vulnerable patients, including neonates and critical or immunocompromised children.

This Special Issue aims to collect articles exploring the PK/PD behavior of “old” and “new” generation antimicrobials in neonates and pediatric patients. Moreover, TDM-based studies performed during routine clinical practice in pediatric patients will be welcomed.

In particular, themes that the editors would like to see addressed in this article collection are the following:

• “Real-life” PK/PD studies involving neonates, infants, children, and adolescents;
• TDM-based strategies for conducting PK/PD studies in pediatric patients;
• Model-informed precision dosing (MIPD) approaches for studying antimicrobials in “real-life” clinical practice;
• PK behavior of antimicrobials in pediatric patients subjected to extracorporeal procedures;
• Validation of new bioanalytical methods and microsampling procedures for conducting PK studies or TDM during routine clinical practice;
• Case reports showing the successful “off-label” use of antimicrobials in neonates and pediatrics;
• Utility of TDM to avoid risks of therapeutic failures, microbial resistance, and adverse drug reactions (ADRs) in pediatric patients;
• Studies on the repurposing of “old” drugs for treating “new” germs;
• Reviews and position papers on the latest recommendation released by regulatory authorities and pediatric infectiology societies on the use of antimicrobials recently introduced in routine clinical practice.

Dr. Raffaele Simeoli
Guest Editor

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