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Developing evidence-based dosing recommendations for intravenous ciprofloxacin in critically ill children: a population pharmacokinetic study using total and unbound concentrations

Pieter-Jan De Sutter (UGent) , Evelyn Dhont (UGent) , Daphné Vens, Peter De Paepe (UGent) , Jef Willems (UGent) , Petra Schelstraete (UGent) , Jan Van Bocxlaer (UGent) , An Vermeulen (UGent) and Pieter De Cock (UGent)
(2025) European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts. In Pediatric Drugs 27(4). p.518-519
Author
Organization
Abstract
Introduction : Optimal antibiotic dosing in critically ill children is influenced by pathophysiological changes and supportive therapies. This study aimed to develop a population pharmacokinetic model for ciprofloxacin in critically ill children to identify predictors of inter-individual variability, evaluate target attainment for both total and unbound exposure, and provide evidencebased dosing recommendations. Methods : A prospective, open-label, multicentric pharmacokinetic (PK) study was conducted in 44 hospitalized children (< 16 years) receiving intravenous ciprofloxacin. Blood and urine samples were collected at two dosing occasions (10 mg/kg every 12h) and drug concentrations were assessed in plasma (total and unbound concentrations) and urine. PK parameters were analysed with population PK modelling using Monolix. Probability of target attainment (PTA) was calculated based on the free or total area under the curve (AUC) and was simulated for different dose regimens of ciprofloxacin. Results : Ciprofloxacin PK was best described with an allometrically scaled two-compartment model. The typical fraction unbound ciprofloxacin in plasma, and the fraction excreted unchanged in urine were 0.52 and 0.89, respectively. Clearance increased with glomerular filtration rate and decreased when children were on mechanical ventilation. For an MIC of 0.25 mg/L, the study dose achieved a PTA of 74.4% for unbound exposure (fAUC/MIC > 72) and 79.3% for total exposure (AUC/MIC > 125). Adequate PTA (≥ 90%) requires 10 mg/kg every 8h in ventilated patients and 15 mg/kg every 8h (off-label) in non-ventilated patients with normal renal function (80-130 mL/min/1.73m²). Conclusion : Standard dosing regimens of ciprofloxacin (20-30 mg/kg per day) fail to achieve adequate target attainment in non-ventilated critically ill children with a normal or elevated renal function. Further research should prospectively evaluate the efficacy and safety of increasing ciprofloxacin doses.
Keywords
Pharmacokinetics, Ciprofloxacin, Pediatrics, Intensive care, PopulationPK

Citation

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MLA
De Sutter, Pieter-Jan, et al. “Developing Evidence-Based Dosing Recommendations for Intravenous Ciprofloxacin in Critically Ill Children: A Population Pharmacokinetic Study Using Total and Unbound Concentrations.” European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts, vol. 27, no. 4, 2025, pp. 518–19.
APA
De Sutter, P.-J., Dhont, E., Vens, D., De Paepe, P., Willems, J., Schelstraete, P., … De Cock, P. (2025). Developing evidence-based dosing recommendations for intravenous ciprofloxacin in critically ill children: a population pharmacokinetic study using total and unbound concentrations. European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts, 27(4), 518–519.
Chicago author-date
De Sutter, Pieter-Jan, Evelyn Dhont, Daphné Vens, Peter De Paepe, Jef Willems, Petra Schelstraete, Jan Van Bocxlaer, An Vermeulen, and Pieter De Cock. 2025. “Developing Evidence-Based Dosing Recommendations for Intravenous Ciprofloxacin in Critically Ill Children: A Population Pharmacokinetic Study Using Total and Unbound Concentrations.” In European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts, 27:518–19.
Chicago author-date (all authors)
De Sutter, Pieter-Jan, Evelyn Dhont, Daphné Vens, Peter De Paepe, Jef Willems, Petra Schelstraete, Jan Van Bocxlaer, An Vermeulen, and Pieter De Cock. 2025. “Developing Evidence-Based Dosing Recommendations for Intravenous Ciprofloxacin in Critically Ill Children: A Population Pharmacokinetic Study Using Total and Unbound Concentrations.” In European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts, 27:518–519.
Vancouver
1.
De Sutter P-J, Dhont E, Vens D, De Paepe P, Willems J, Schelstraete P, et al. Developing evidence-based dosing recommendations for intravenous ciprofloxacin in critically ill children: a population pharmacokinetic study using total and unbound concentrations. In: European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts. 2025. p. 518–9.
IEEE
[1]
P.-J. De Sutter et al., “Developing evidence-based dosing recommendations for intravenous ciprofloxacin in critically ill children: a population pharmacokinetic study using total and unbound concentrations,” in European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts, Nijmegen, 2025, vol. 27, no. 4, pp. 518–519.
@inproceedings{01K6DGAMC6S1JWQ32YDN3BNJ1E,
  abstract     = {{Introduction : 
Optimal antibiotic dosing in critically ill children is influenced by pathophysiological changes and supportive therapies. This study aimed to develop a population pharmacokinetic model for ciprofloxacin in critically ill children to identify predictors of inter-individual variability, evaluate target attainment for both total and unbound exposure, and provide evidencebased dosing recommendations. 

Methods : 
A prospective, open-label, multicentric pharmacokinetic (PK) study was conducted in 44 hospitalized children (< 16 years) receiving intravenous ciprofloxacin. Blood and urine samples were collected at two dosing occasions (10 mg/kg every 12h) and drug concentrations were assessed in plasma (total and unbound concentrations) and urine. PK parameters were analysed with population PK modelling using Monolix. Probability of target attainment (PTA) was calculated based on the free or total area under the curve (AUC) and was simulated for different dose regimens of ciprofloxacin. 

Results : 
Ciprofloxacin PK was best described with an allometrically scaled two-compartment model. The typical fraction unbound ciprofloxacin in plasma, and the fraction excreted unchanged in urine were 0.52 and 0.89, respectively. Clearance increased with glomerular filtration rate and decreased when children were on mechanical ventilation. For an MIC of 0.25 mg/L, the study dose achieved a PTA of 74.4% for unbound exposure (fAUC/MIC > 72) and 79.3% for total exposure (AUC/MIC > 125). Adequate PTA (≥ 90%) requires 10 mg/kg every 8h in ventilated patients and 15 mg/kg every 8h (off-label) in non-ventilated patients with normal renal function (80-130 mL/min/1.73m²). 

Conclusion : 
Standard dosing regimens of ciprofloxacin (20-30 mg/kg per day) fail to achieve adequate target attainment in non-ventilated critically ill children with a normal or elevated renal function. Further research should prospectively evaluate the efficacy and safety of increasing ciprofloxacin doses.}},
  author       = {{De Sutter, Pieter-Jan and Dhont, Evelyn and Vens, Daphné and De Paepe, Peter and Willems, Jef and Schelstraete, Petra and Van Bocxlaer, Jan and Vermeulen, An and De Cock, Pieter}},
  booktitle    = {{European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP), 21st Congress, Abstracts}},
  issn         = {{1174-5878}},
  keywords     = {{Pharmacokinetics,Ciprofloxacin,Pediatrics,Intensive care,PopulationPK}},
  language     = {{eng}},
  location     = {{Nijmegen}},
  number       = {{4}},
  pages        = {{518--519}},
  title        = {{Developing evidence-based dosing recommendations for intravenous ciprofloxacin in critically ill children: a population pharmacokinetic study using total and unbound concentrations}},
  url          = {{https://doi.org/10.1007/s40272-025-00705-6}},
  volume       = {{27}},
  year         = {{2025}},
}