Trial reportAntimicrobial agents and chemotherapy2016
Population Pharmacokinetics of Isavuconazole from Phase 1 and Phase 3 (SECURE) Trials in Adults and Target Attainment in Patients with Invasive Infections Due to Aspergillus and Other Filamentous Fungi.
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 76 papers, 2 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
76 citing papers in PubMed, 2 syntheses or guidelines pooled it, 135 citations in OpenAlex.
- Guideline
- Efficacy and safety of isavuconazole for invasive fungal infections: A systematic review and meta-analysis of randomized controlled trials.Medical mycology · 2025Pooled it
- Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects.Clinical pharmacology in drug development · 2022Trial
- Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation.Journal of clinical pharmacology · 2022Trial
- Pharmacokinetics and Bioequivalence of Isavuconazole Administered as Isavuconazonium Sulfate Intravenous Solution via Nasogastric Tube or Orally in Healthy Subjects.Antimicrobial agents and chemotherapy · 2021Trial
- Variability and exposure-response relationships of isavuconazole plasma concentrations in the Phase 3 SECURE trial of patients with invasive mould diseases.The Journal of antimicrobial chemotherapy · 2019Trial
- Exposure-Response Relationships for Isavuconazole in Patients with Invasive Aspergillosis and Other Filamentous Fungi.Antimicrobial agents and chemotherapy · 2017Trial
- Impact of Mucositis on Absorption and Systemic Drug Exposure of Isavuconazole.Antimicrobial agents and chemotherapy · 2017Trial
- Development of an isavuconazole physiologically-based pharmacokinetic model for adult and pediatric populations.Journal of pharmacokinetics and pharmacodynamics · 2026Article
- Use of Isavuconazole in the Treatment of Cryptococcosis: A Real-World Case Series.Infectious diseases and therapy · 2026Article
- Pharmacokinetics of Isavuconazole in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO) Support: A Prospective Exploratory Observational Study.Pharmaceutics · 2026Article
- Population pharmacokinetics, target attainment and individualized dosing of isavuconazole in critically ill adults receiving extracorporeal membrane oxygenation.JAC-antimicrobial resistance · 2026Article
- Characterization of isavuconazole pharmacokinetics and pharmacodynamics in a real-life cohort.JAC-antimicrobial resistance · 2026Article
- Evaluation of anAntimicrobial agents and chemotherapy · 2026Article
- Isavuconazole therapeutic drug monitoring in real-world clinical practice: an age-stratified analysis of determinants.Frontiers in pharmacology · 2026Article
- Therapeutic drug monitoring-guided optimization of isavuconazole dose for ICU patients with refractory pulmonary aspergillosis: case report.Frontiers in medicine · 2026Article
- Exploratory model-based optimizing isavuconazole dosing regimens forFrontiers in cellular and infection microbiology · 2026Article
- Prospective study of pharmacokinetics of isavuconazole in critically ill patients undergoing continuous hemodialysis with and without acute-on-chronic liver failure.Annals of intensive care · 2026Article
- Real-World Experience with Isavuconazole for Invasive Aspergillosis in Hematologic Patients with and Without COVID-19 in Brazil.Journal of fungi (Basel, Switzerland) · 2025Article
- Optimization of Isavuconazole Dosing in Patients with Invasive Fungal Infections Through Therapeutic Drug Monitoring: Real-World Clinical Practice Experience.Life (Basel, Switzerland) · 2025Article
16 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
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Isavuconazole, the active moiety of the water-soluble prodrug isavuconazonium sulfate, is a triazole antifungal agent used for the treatment of invasive fungal infections. The objective of this analysis was to develop a population pharmacokinetic (PPK) model to identify covariates that affect isavuconazole pharmacokinetics and to determine the probability of target attainment (PTA) for invasive aspergillosis patients. Data from nine phase 1 studies and one phase 3 clinical trial (SECURE) were pooled to develop the PPK model (NONMEM, version 7.2). Stepwise covariate modeling was performed in Perl-speaks-NONMEM, version 3.7.6. The area under the curve (AUC) at steady state was calculated for 5,000 patients by using Monte Carlo simulations. The PTA using the estimated pharmacodynamic (PD) target value (total AUC/MIC ratio) estimated from in vivo PD studies of invasive aspergillosis over a range of MIC values was calculated using simulated patient AUC values. A two-compartment model with a Weibull absorption function and a first-order elimination process adequately described plasma isavuconazole concentrations. The mean estimate for isavuconazole clearance was 2.360 liters/h (percent coefficient of variation [%CV], 34%), and the mean AUC from 0 to 24 h (AUC0-24) was ∼100 mg·h/liter. Clearance was approximately 36% lower in Asians than in Caucasians. The PTA calculated over a range of MIC values by use of the nonneutropenic murine efficacy index corresponding to 90% survival indicated that adequate isavuconazole exposures were achieved in >90% of simulated patients to treat infections with MICs up to and including 1 mg/liter according to European Committee on Antimicrobial Susceptibility Testing methodology and in >90% of simulated patients for infections with MICs up to and including 0.5 mg/liter according to Clinical and Laboratory Standards Institute methodology. The highest MIC result for PTA was the same for Caucasian and Asian patients.
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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.