Trial reportAntimicrobial agents and chemotherapy2010
Pharmacokinetics, safety, and tolerability of voriconazole in immunocompromised children.
Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 4 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
56 citing papers in PubMed, 4 syntheses or guidelines pooled it, 139 citations in OpenAlex.
- Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP2C19 and Voriconazole Therapy.Clinical pharmacology and therapeutics · 2017Guideline
- Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.The Pediatric infectious disease journal · 2013Guideline
- Antifungal therapy in children: an update.European journal of pediatrics · 2013Pooled it
- Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis.The Pediatric infectious disease journal · 2017Trial
- Pharmacokinetics and safety of voriconazole intravenous-to-oral switch regimens in immunocompromised Japanese pediatric patients.Antimicrobial agents and chemotherapy · 2015Trial
- A physiologically based pharmacokinetic model for voriconazole disposition predicts intestinal first-pass metabolism in children.Clinical pharmacokinetics · 2014Trial
- Integrated population pharmacokinetic analysis of voriconazole in children, adolescents, and adults.Antimicrobial agents and chemotherapy · 2012Trial
- Comparison of pharmacokinetics and safety of voriconazole intravenous-to-oral switch in immunocompromised children and healthy adults.Antimicrobial agents and chemotherapy · 2011Trial
- Comparison of pharmacokinetics and safety of voriconazole intravenous-to-oral switch in immunocompromised adolescents and healthy adults.Antimicrobial agents and chemotherapy · 2011Trial
- Optimization strategies for voriconazole dosing in pediatric populations: integrating therapeutic indications and age-stratified pharmacokinetics.Antimicrobial agents and chemotherapy · 2026Article
- Comparative pharmacokinetics of voriconazole between elderly and young adult patients: a population pharmacokinetic study.Journal of pharmaceutical policy and practice · 2026Article
- Pediatric vs. Adult Invasive Aspergillosis in Cancer and Hematopoietic Transplant Patients: Insights from a Matched Cohort at a Tertiary Cancer Center.Journal of fungi (Basel, Switzerland) · 2025Article
- Therapeutic Drug Monitoring of Voriconazole in Critically Ill Pediatric Patients: A Single-Center Retrospective Study.Paediatric drugs · 2024Article
- Fixed-Dose Combination Formulations in Solid Oral Drug Therapy: Advantages, Limitations, and Design Features.Pharmaceutics · 2024Review
- An update on the global treatment of invasive fungal infections.Future microbiology · 2023Review
- Population pharmacokinetics of voriconazole and the role of CYP2C19 genotype on treatment optimization in pediatric patients.PloS one · 2023Article
- Pharmacokinetic interaction of voriconazole and clarithromycin in Pakistani healthy male volunteers: a single dose, randomized, crossover, open-label study.Frontiers in pharmacology · 2023Article
- Higher Weight-Based Doses Are Required to Achieve and Maintain Therapeutic Voriconazole Serum Trough Concentrations in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Therapeutic drug monitoring andTranslational pediatrics · 2022Article
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 9 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetics of voriconazole in children receiving 4 mg/kg intravenously (i.v.) demonstrate substantially lower plasma exposures (as defined by area under the concentration-time curve [AUC]) than those in adults receiving the same therapeutic dosage. These differences in pharmacokinetics between children and adults limit accurate prediction of pediatric voriconazole exposure based on adult dosages. We therefore studied the pharmacokinetics and tolerability of higher dosages of an i.v.-to-oral regimen of voriconazole in immunocompromised children aged 2 to <12 years in two dosage cohorts for the prevention of invasive fungal infections. The first cohort received 4 mg/kg i.v. every 12 h (q12h), then 6 mg/kg i.v. q12h, and then 4 mg/kg orally (p.o.) q12h; the second received 6 mg/kg i.v. q12h, then 8 mg/kg i.v. q12h, and then 6 mg/kg p.o. q12h. The mean values for the AUC over the dosing interval (AUCτ) for 4 mg/kg and 6 mg/kg i.v. in cohort 1 were 11,827 and 22,914 ng.h/ml, respectively, whereas the mean AUCτ values for 6 mg/kg and 8 mg/kg i.v. in cohort 2 were 17,249 and 29,776 ng.h/ml, respectively. High interpatient variability was observed. The bioavailability of the oral formulation in children was approximately 65%. The safety profiles were similar in the two cohorts and age groups. The most common treatment-related adverse event was increased gamma glutamyl transpeptidase levels. There was no correlation between adverse events and voriconazole exposure. In summary, voriconazole was tolerated to a similar degree regardless of dosage and age; the mean plasma AUCτ for 8 mg/kg i.v. in children approached that for 4 mg/kg i.v. in adults, thus representing a rationally selected dosage for the pediatric population.
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