Trial reportAntimicrobial agents and chemotherapy2012
Short versus long infusion of meropenem in very-low-birth-weight neonates.
Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
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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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- 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
- Plasma and CSF pharmacokinetics of meropenem in neonates and young infants: results from the NeoMero studies.The Journal of antimicrobial chemotherapy · 2018Trial
- Identifying optimal dosing strategies for meropenem in the paediatric intensive care unit through modelling and simulation.The Journal of antimicrobial chemotherapy · 2024Article
- Clinical Challenge: Standard Versus Extended Meropenem Infusion in Children.Turkish archives of pediatrics · 2024Article
- Extended infusion of β-lactams significantly reduces mortality and enhances microbiological eradication in paediatric patients: a systematic review and meta-analysis.EClinicalMedicine · 2023Article
- Predicting Volume of Distribution in Neonates: Performance of Physiologically Based Pharmacokinetic Modelling.Pharmaceutics · 2023Article
- Population PK/PD modelling of meropenem in preterm newborns based on therapeutic drug monitoring data.Frontiers in pharmacology · 2023Article
- Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022Review
- Extended Infusion of Meropenem in Neonatal Sepsis: A Historical Cohort Study.Antibiotics (Basel, Switzerland) · 2022Article
- A Review of Extended and Continuous Infusion Beta-Lactams in Pediatric Patients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Extended or Continuous Infusion of Carbapenems in Children with Severe Infections: A Systematic Review and Narrative Synthesis.Antibiotics (Basel, Switzerland) · 2021Review
- Variation in Target Attainment of Beta-Lactam Antibiotic Dosing Between International Pediatric Formularies.Clinical pharmacology and therapeutics · 2021Review
- Optimizing Antibiotic Treatment Strategies for Neonates and Children: Does Implementing Extended or Prolonged Infusion Provide any Advantage?Antibiotics (Basel, Switzerland) · 2020Review
- Dosage Regimens for Meropenem in Children with Pseudomonas Infections Do Not Meet Serum Concentration Targets.Clinical and translational science · 2020Article
- Neonatal Therapeutics: Considerations for Dosing.American journal of perinatology · 2019Review
- Towards a Generic Tool for Prediction of Meropenem Systemic and Infection-Site Exposure: A Physiologically Based Pharmacokinetic Model for Adult Patients with Pneumonia.Drugs in R&D · 2019Article
- Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance.Clinical pharmacokinetics · 2019Review
- Dosing antibiotics in neonates: review of the pharmacokinetic data.Future microbiology · 2017Article
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
Abstract
Prolonged infusion of meropenem has been suggested in studies with population pharmacokinetic modeling but has not been tested in neonates. We compared the steady-state pharmacokinetics (PK) of meropenem given as a short (30-min) or prolonged (4-h) infusion to very-low-birth-weight (gestational age, <32 weeks; birth weight, <1,200 g) neonates to define the appropriate dosing regimen for a phase 3 efficacy study. Short (n = 9) or prolonged (n = 10) infusions of meropenem were given at a dose of 20 mg/kg every 12 h. Immediately before and 0.5, 1.5, 4, 8, and 12 h after the 4th to 7th doses of meropenem, blood samples were collected. Meropenem concentrations were measured by ultrahigh-performance liquid chromatography. PK analysis was performed with WinNonlin software, and modeling was performed with NONMEM software. A short infusion resulted in a higher mean drug concentration in serum (C(max)) than a prolonged infusion (89 versus 54 mg/liter). In all but two patients in the prolonged-infusion group, the free serum drug concentration was above the MIC (2 mg/liter) 100% of the time. Meropenem clearance (CL) was not influenced by postnatal or postmenstrual age. In population PK analysis, a one-compartment model provided the best fit and the steady-state distribution volume (V(ss)) was scaled with body weight and CL with a published renal maturation function. The covariates serum creatinine and postnatal and gestational ages did not improve the model fit. The final parameter estimates were a V(ss) of 0.301 liter/kg and a CL of 0.061 liter/h/kg. Meropenem infusions of 30 min are acceptable as they balance a reasonably high C(max) with convenience of dosing. In very-low-birth-weight neonates, no dosing adjustment is needed over the first month of life.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.