ArticleAntimicrobial agents and chemotherapy2007
Single-dose pharmacokinetics of intravenous itraconazole and hydroxypropyl-beta-cyclodextrin in infants, children, and adolescents.
Article in Antimicrobial agents and chemotherapy, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01557985 (Single Dose Pharmacokinetics and Pharmacodynamics of Bupivacaine Following Transversus Abdominis Plane), which is not on this map. Cited by 20 papers.
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.
Single Dose Pharmacokinetics and Pharmacodynamics of Bupivacaine Following Transversus Abdominis Plane (TAP) Block in Neonates
Who cites it
20 citing papers in PubMed, 53 citations in OpenAlex.
- Efficacy of itraconazole prophylaxis for autologous stem cell transplantation in children with high-risk solid tumors: a prospective double-blind randomized study.Yonsei medical journal · 2011Trial
- Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials.Current research in pharmacology and drug discovery · 2025Review
- How Do Cyclodextrins and Dextrans Affect the Gut Microbiome? Review of Prebiotic Activity.Molecules (Basel, Switzerland) · 2024Review
- Advanced In Vivo Prediction by Introducing Biphasic Dissolution Data into PBPK Models.Pharmaceutics · 2023Article
- Influence of Gender, Body Mass Index, and Age on the Pharmacokinetics of Itraconazole in Healthy Subjects: Non-Compartmental Versus Compartmental Analysis.Frontiers in pharmacology · 2022Article
- Clinical Pharmacokinetics of Triazoles in Pediatric Patients.Clinical pharmacokinetics · 2021Review
- Pharmacokinetics of Diclofenac and Hydroxypropyl-β-Cyclodextrin (HPβCD) Following Administration of Injectable HPβCD-Diclofenac in Subjects With Mild to Moderate Renal Insufficiency or Mild Hepatic Impairment.Clinical pharmacology in drug development · 2018Article
- Antifungal azoles itraconazole and posaconazole exhibit potent in vitro antiviral activity against clinical isolates of parechovirus A3 (Picornaviridae).Antiviral research · 2018Article
- Cyclodextrins as Emerging Therapeutic Tools in the Treatment of Cholesterol-Associated Vascular and Neurodegenerative Diseases.Molecules (Basel, Switzerland) · 2016Review
- Efficacy and safety of itraconazole use in infants.World journal of pediatrics : WJP · 2016Review
- Pharmacokinetics and bioavailability of itraconazole oral solution in cats.Journal of feline medicine and surgery · 2016Article
- Successful empirical antifungal therapy of intravenous itraconazole with pharmacokinetic evidence in pediatric cancer patients undergoing hematopoietic stem cell transplantation.Clinical drug investigation · 2015Article
- Association of systolic blood pressure drop with intravenous administration of itraconazole in children with hemato-oncologic disease.Drug design, development and therapy · 2015Article
- Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.Drugs · 2014Review
- Pharmacokinetic/pharmacodynamic modelling approaches in paediatric infectious diseases and immunology.Advanced drug delivery reviews · 2014Review
- Pharmacokinetics and pharmacodynamics of antifungals in children and their clinical implications.Clinical pharmacokinetics · 2014Review
- Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology.The Journal of antimicrobial chemotherapy · 2014Review
- Antifungal agents and therapy for infants and children with invasive fungal infections: a pharmacological perspective.British journal of clinical pharmacology · 2013Review
- Review
- Interspecies scaling for the prediction of drug clearance in children: application of maximum lifespan potential and an empirical correction factor.Clinical pharmacokinetics · 2010Article
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
This investigation was designed to evaluate the single-dose pharmacokinetics of itraconazole, hydroxyitraconazole, and hydroxypropyl-beta-cyclodextrin (HP-beta-CD) after intravenous administration to children at risk for fungal infection. Thirty-three children aged 7 months to 17 years received a single dose of itraconazole (2.5 mg/kg in 0.1-g/kg HP-beta-CD) administered over 1 h by intravenous infusion. Plasma samples for the determination of the analytes of interest were drawn over 120 h and analyzed by high-pressure liquid chromatography, and the pharmacokinetics were determined by traditional noncompartmental analysis. Consistent with the role of CYP3A4 in the biotransformation of itraconazole, a substantial degree of variability was observed in the pharmacokinetics of this drug after IV administration. The maximum plasma concentrations (C(max)) for itraconazole, hydroxyitraconazole, and HP-beta-CD averaged 1,015 +/- 692 ng/ml, 293 +/- 133 ng/ml, and 329 +/- 200 mug/ml, respectively. The total body exposures (area under the concentration-time curve from 0 to 24 h) for itraconazole, hydroxyitraconazole, and HP-beta-CD averaged 4,922 +/- 6,784 ng.h/ml, 3,811 +/- 2,794 ng.h/ml, and 641.5 +/- 265.0 mug.h/ml, respectively, with no significant age dependence observed among the children evaluated. Similarly, there was no relationship between age and total body clearance (702.8 +/- 499.4 ml/h/kg); however, weak associations between age and the itraconazole distribution volume (r(2) = 0.18, P = 0.02), C(max) (r(2) = 0.14, P = 0.045), and terminal elimination rate (r(2) = 0.26, P < 0.01) were noted. Itraconazole infusion appeared to be well tolerated in this population with a single adverse event (stinging at the site of infusion) deemed to be related to study drug administration. Based on the findings of this investigation, it appears that intravenous itraconazole can be administered to infants beyond 6 months, children, and adolescents using a weight-normalized approach to 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.