Trial reportAntimicrobial agents and chemotherapy2004
Pharmacokinetics and safety of intravenous voriconazole in children after single- or multiple-dose administration.
Trial report in Antimicrobial agents and chemotherapy, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 10 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
92 citing papers in PubMed, 10 syntheses or guidelines pooled it, 335 citations in OpenAlex.
- Clinical application of voriconazole in pediatric patients: a systematic review.Italian journal of pediatrics · 2024Pooled it
- 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
- 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
- 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
- Observational study of the clinical efficacy of voriconazole and its relationship to plasma concentrations in patients.Antimicrobial agents and chemotherapy · 2011Pooled it
- Antifungal therapy in infants and children with proven, probable or suspected invasive fungal infections.The Cochrane database of systematic reviews · 2010Pooled it
- Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2009Guideline
- Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2009Guideline
- Pre-emptiveFrontiers in pharmacology · 2026Trial
- 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
- Pharmacokinetics, safety, and tolerability of voriconazole in immunocompromised children.Antimicrobial agents and chemotherapy · 2010Trial
- Voriconazole pharmacokinetics and safety in immunocompromised children compared to adult patients.Antimicrobial agents and chemotherapy · 2010Trial
- Posaconazole plasma concentrations in juvenile patients with invasive fungal infection.Antimicrobial agents and chemotherapy · 2007Trial
- Variability of voriconazole plasma levels measured by new high-performance liquid chromatography and bioassay methods.Antimicrobial agents and chemotherapy · 2007Trial
32 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 6 countries.
Funding
Abstract
We conducted a multicenter study of the safety, tolerability, and plasma pharmacokinetics of the parenteral formulation of voriconazole in immunocompromised pediatric patients (2 to 11 years old). Single doses of 3 or 4 mg/kg of body weight were administered to six and five children, respectively. In the multiple-dose study, 28 patients received loading doses of 6 mg/kg every 12 h on day 1, followed by 3 mg/kg every 12 h on day 2 to day 4 and 4 mg/kg every 12 h on day 4 to day 8. Standard population pharmacokinetic approaches and generalized additive modeling were used to construct the structural pharmacokinetic and covariate models used in this analysis. In contrast to that in adult healthy volunteers, elimination of voriconazole was linear in children following doses of 3 and 4 mg/kg every 12 h. Body weight was more influential than age in accounting for the observed variability in voriconazole pharmacokinetics. Elimination capacity correlated with the CYP2C19 genotype. Exposures were similar at 4 mg/kg every 12 h in children (median area under the concentration-time curve (AUC), 14,227 ng. h/ml) and 3 mg/kg in adults (median AUC, 13,855 ng. h/ml). Visual disturbances occurred in 5 (12.8%) of the 39 patients and were the only drug-related adverse events that occurred more than once. No withdrawals from the study were related to voriconazole. We conclude that pediatric patients have a higher capacity for elimination of voriconazole per kilogram of body weight than do adult healthy volunteers and that dosages of 4 mg/kg may be required in children to achieve exposures consistent with those in adults following dosages of 3 mg/kg.
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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.