Trial reportEuropean journal of clinical pharmacology2013
Population pharmacokinetics of piperacillin/tazobactam in neonates and young infants.
Trial report in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Assessment of Piperacillin-Tazobactam Population Pharmacokinetic Models in Neonates: An External Validation.European journal of drug metabolism and pharmacokinetics · 2025Pooled it
- Scaling beta-lactam antimicrobial pharmacokinetics from early life to old age.British journal of clinical pharmacology · 2019Pooled it
- Evaluation of evidence for pharmacokinetics-pharmacodynamics-based dose optimization of antimicrobials for treating Gram-negative infections in neonates.The Indian journal of medical research · 2017Pooled it
- Population pharmacokinetics and dose optimization of piperacillin-tazobactam in premature and term neonates with severe infections.Antimicrobial agents and chemotherapy · 2026Article
- Development of population pharmacokinetic models of total and free piperacillin in critically ill children and young adults for Monte Carlo simulations and model-informed precision dosing.The Journal of antimicrobial chemotherapy · 2026Article
- A Pooled Pharmacokinetic Analysis for Piperacillin/Tazobactam Across Different Patient Populations: From Premature Infants to the Elderly.Clinical pharmacokinetics · 2025Article
- Population Pharmacokinetics and Dose Optimization of Piperacillin in Infants and Children with Pneumonia.Paediatric drugs · 2025Article
- External Evaluation of Population Pharmacokinetic Models of Piperacillin in Preterm and Term Patients from Neonatal Intensive Care.European journal of drug metabolism and pharmacokinetics · 2024Article
- Accuracy of antibiotic concentrations in drug dispensing in neonates: a laboratory-based study.BMJ paediatrics open · 2023Article
- Predicting Volume of Distribution in Neonates: Performance of Physiologically Based Pharmacokinetic Modelling.Pharmaceutics · 2023Article
- Suppressive effect of therapeutic antibiotic regimen on antipneumococcal Th1/Th17 responses in neonatal mice.Pediatric research · 2023Article
- Case report: Acute hepatitis in neonates with COVID-19 during the Omicron SARS-CoV-2 variant wave: a report of four cases.Frontiers in pediatrics · 2023Article
- Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022Review
- β-lactam precision dosing in critically ill children: Current state and knowledge gaps.Frontiers in pharmacology · 2022Review
- Drug Clearance in Neonates: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction.Clinical pharmacokinetics · 2021Article
- Piperacillin-Tazobactam in Intensive Care Units: A Review of Population Pharmacokinetic Analyses.Clinical pharmacokinetics · 2021Review
- Cross-sectional study of drug utilisation in a Chinese neonatal unit.The Journal of international medical research · 2020Article
- Tolerability, Safety, Pharmacokinetics and Drug Interaction of Cefotaxime Sodium-Tazobactam Sodium Injection (6:1) Following Single and Multiple Intravenous Doses in Chinese Healthy Subjects.Frontiers in pharmacology · 2020Article
- Population pharmacokinetic analysis of linezolid in patients with different types of shock: Effect of platelet count.Experimental and therapeutic medicine · 2019Article
- Drugs for the Prevention and Treatment of Sepsis in the Newborn.Clinics in perinatology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo develop population pharmacokinetic (PK) models for piperacillin/tazobactam in neonates and infants of less than 2 months of age in order to determine the appropriate dosing regimen and provide a rational basis for the development of preliminary dosing guidelines suitable for this population.
methodsA two-stage, open-label study was conducted in neonates and infants less than 2 months of age in the neonatal intensive care unit (NICU). A total of 207 piperacillin and 204 tazobactam concentration-time data sets from 71 patients were analyzed using a nonlinear mixed-effect modeling approach (NONMEM VII). PK models were developed for piperacillin and tazobactam. The final models were evaluated using both bootstrap and visual predictive checks. External model evaluations were made in 20 additional patients.
resultsFor neonates and young infants less than 2 months of age, the median central clearance was 0.133 and 0.149 L/h/kg for piperacillin and tazobactam, respectively. Postmenstrual age (PMA) was identified as the most significant covariate on central clearance of piperacillin and tazobactam. However, the combination of current bodyweight (BW) and postnatal age proved to be superior to PMA alone. BW was the most important covariate for apparent central volume of distribution. Both internal and external evaluations supported the prediction of the final piperacillin and tazobactam PK models. The dosing strategy 44.44/5.56 mg/kg/dose piperacillin/tazobactam every 8 or 12 h evaluated in this study achieved the pharmacodynamic target (free piperacillin concentrations >4 mg/L for more than 50 % of the dosing interval) in about 67 % of infants.
conclusionsPopulation PK models accurately described the PK profiles of piperacillin/tazobactam in infants less than 2 months of age. The results indicated that higher doses or more frequent dosing regimens may be required for controlling infection in this population in NICU.
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