Trial reportAntimicrobial agents and chemotherapy2016
Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.
Trial report in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- The efficacy and safety of fluconazole in preventing invasive fungal infection in very low birth weight infants: a systematic review and meta-analysis.Italian journal of pediatrics · 2023Pooled it
- Choosing the Right Antifungal Agent in ICU Patients.Advances in therapy · 2019Pooled it
- Preterm Physiologically Based Pharmacokinetic Model. Part II: Applications of the Model to Predict Drug Pharmacokinetics in the Preterm Population.Clinical pharmacokinetics · 2020Trial
- Population Pharmacokinetic Study of Prophylactic Fluconazole in Preterm Infants for Prevention of Invasive Candidiasis.Antimicrobial agents and chemotherapy · 2019Trial
- Effect of fluconazole prophylaxis on Candida fluconazole susceptibility in premature infants.The Journal of antimicrobial chemotherapy · 2018Trial
- Irrational and Inappropriate Use of Antifungals in the NICU: A Narrative Review.Antibiotics (Basel, Switzerland) · 2026Review
- Fluconazole Dosing for the Prevention ofPharmaceutics · 2025Article
- Population pharmacokinetics of fluconazole for prevention or treatment of invasive candidiasis in Chinese young infants.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Invasive Candida Infections in Neonatal Intensive Care Units: Risk Factors and New Insights in Prevention.Pathogens (Basel, Switzerland) · 2024Review
- Physicochemical Characteristics of Antimicrobials and Practical Recommendations for Intravenous Administration: A Systematic Review.Antibiotics (Basel, Switzerland) · 2023Review
- Pharmacokinetic comparability between two populations using nonlinear mixed effect models: a Monte Carlo study.Journal of pharmacokinetics and pharmacodynamics · 2023Article
- Updates in the Pharmacologic Prophylaxis and Treatment of Invasive Candidiasis in the Pediatric and Neonatal Intensive Care Units: Updates in the Pharmacologic Prophylaxis.Current treatment options in infectious diseases · 2022Article
- Fluconazole Population Pharmacokinetics after Fosfluconazole Administration and Dosing Optimization in Extremely Low-Birth-Weight Infants.Microbiology spectrum · 2022Article
- Review of Scavenged Sampling for Sustainable Therapeutic Drug Monitoring: Do More With Less.Therapeutic drug monitoring · 2022Review
- The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.Frontiers in pharmacology · 2022Article
- Challenges in conducting paediatric trials with off-patent drugs.Contemporary clinical trials communications · 2021Article
- Clinical Pharmacokinetics of Triazoles in Pediatric Patients.Clinical pharmacokinetics · 2021Review
- Developing a SWATH capillary LC-MS/MS method for simultaneous therapeutic drug monitoring and untargeted metabolomics analysis of neonatal plasma.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2021Article
- Optimization of Fluconazole Dosing for the Prevention and Treatment of Invasive Candidiasis Based on the Pharmacokinetics of Fluconazole in Critically Ill Patients.Antimicrobial agents and chemotherapy · 2021Observational
- A meta-analysis of fluconazole for the prevention of invasive fungal infection in preterm infants.American journal of translational research · 2021Review
Corrections and comments
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Authors and funding
14 authors at 11 institutions in 1 country.
Funding
Abstract
Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.
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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.