ArticleThe Pediatric infectious disease journal2011
Fluconazole loading dose pharmacokinetics and safety in infants.
Article in The Pediatric infectious disease journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 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
44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 120 citations in OpenAlex.
- Pharmacokinetics of Commonly Used Medications in Children Receiving Continuous Renal Replacement Therapy: A Systematic Review of Current Literature.Clinical pharmacokinetics · 2022Pooled it
- Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Safety of fluconazole in paediatrics: a systematic review.European journal of clinical pharmacology · 2013Pooled it
- Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.British journal of clinical pharmacology · 2018Trial
- Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation.Antimicrobial agents and chemotherapy · 2015Trial
- Fluconazole Dosing for the Prevention ofPharmaceutics · 2025Article
- Addressing the silent threat: managing invasiveFrontiers in pediatrics · 2025Review
- Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Population pharmacokinetics of fluconazole for prevention or treatment of invasive candidiasis in Chinese young infants.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Antibiotics, Analgesic Sedatives, and Antiseizure Medications Frequently Used in Critically Ill Neonates: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- 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
- Medication Use in the Neonatal Intensive Care Unit and Changes from 2010 to 2018.The Journal of pediatrics · 2022Article
- Clinical Pharmacokinetics of Triazoles in Pediatric Patients.Clinical pharmacokinetics · 2021Review
- Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Review
- Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.Paediatric drugs · 2020Review
- One Size Fits All? Application of Susceptible-Dose-Dependent Breakpoints to Pediatric Patients and Laboratory Reporting.Journal of clinical microbiology · 2019Review
- Dexmedetomidine Pharmacokinetics and a New Dosing Paradigm in Infants Supported With Cardiopulmonary Bypass.Anesthesia and analgesia · 2019Article
- Suggestions for Model-Informed Precision Dosing to Optimize Neonatal Drug Therapy.Journal of clinical pharmacology · 2019Review
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundInvasive candidiasis is a leading cause of morbidity and mortality in critically ill infants. Prompt administration of fluconazole and achievement of the therapeutic target (area under the curve 0 to 24 hours >400 mg*h/L) improve outcomes in candidemic patients. A loading dose of fluconazole is advised for older patients but has not been evaluated in infants. We sought to determine the pharmacokinetics and safety of a fluconazole loading dose in infants at risk for invasive fungal infection.
methodsWe enrolled 10 hospitalized infants <60 days old with suspected systemic fungal infection in this open-label study; 9 received a 25-mg/kg fluconazole loading dose followed by a maintenance dose of 12 mg/kg every 24 hours for 4 additional days. Plasma samples were obtained following the loading and steady-state doses (doses 3-5). We used a 1-compartment model to fit the data to estimate pharmacokinetic indices.
resultsData from 57 drug concentrations obtained from 8 infants (median postnatal age, 16 days [interquartile range, 13-32] and median gestational age, 37 weeks [35-38]) showed that the median fluconazole area under the curve 0 to 24 hours (mg*h/L) in this population was 479 (347-496). Of the 8 infants who received the loading dose, 5 (63%) achieved the therapeutic target on the first day of dosing, and all infants achieved a fluconazole 24-hour trough concentration >8 μg/mL. No adverse events were thought to be related to fluconazole therapy.
conclusionsA loading dose of fluconazole (25 mg/kg) was safe in this small cohort of young infants and achieved the therapeutic target more rapidly than traditional dosing.
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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.