Trial reportThe Journal of antimicrobial chemotherapy2019
Variability and exposure-response relationships of isavuconazole plasma concentrations in the Phase 3 SECURE trial of patients with invasive mould diseases.
Trial report in The Journal of antimicrobial chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
36 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guideline
- Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects.Clinical pharmacology in drug development · 2022Trial
- Characterization of isavuconazole pharmacokinetics and pharmacodynamics in a real-life cohort.JAC-antimicrobial resistance · 2026Article
- Liver Necrosis in a Patient Receiving Isavuconazole: Making the Case for Therapeutic Drug Monitoring.Open forum infectious diseases · 2026Article
- Pharmacokinetic Interaction Between Isavuconazole and Rifabutin in a Real-World Setting.Mycoses · 2026Article
- Optimization of Isavuconazole Dosing in Patients with Invasive Fungal Infections Through Therapeutic Drug Monitoring: Real-World Clinical Practice Experience.Life (Basel, Switzerland) · 2025Article
- [S1 guideline: diagnosis and treatment of invasive pulmonary aspergillosis in critically ill/intensive care patients].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025Review
- An Overview of Isavuconazole Clinical Use: A Multicentre Analysis of Indications, Exposure and Hepatic Safety.Clinical drug investigation · 2025Article
- Isavuconazole as initial antifungal therapy combined with surgical management of pediatric pulmonary mucormycosis: a case report and literature review.Frontiers in pediatrics · 2025Article
- Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.Antibiotics (Basel, Switzerland) · 2024Article
- Isavuconazole Exposure in Critically Ill Patients Treated with Extracorporeal Membrane Oxygenation: Two Case Reports and a Narrative Literature Review.Antibiotics (Basel, Switzerland) · 2023Article
- Epidemiology, Modern Diagnostics, and the Management of Mucorales Infections.Journal of fungi (Basel, Switzerland) · 2023Review
- Clinical Features and Treatment Progress of Invasive Mucormycosis in Patients with Hematological Malignancies.Journal of fungi (Basel, Switzerland) · 2023Review
- A Hybrid Algorithm Combining Population Pharmacokinetic and Machine Learning for Isavuconazole Exposure Prediction.Pharmaceutical research · 2023Article
- What Is New in Pulmonary Mucormycosis?Journal of fungi (Basel, Switzerland) · 2023Review
- Variability of Isavuconazole Trough Concentrations during Longitudinal Therapeutic Drug Monitoring.Journal of clinical medicine · 2022Article
- Challenges in the Treatment of Invasive Aspergillosis in Immunocompromised Children.Antimicrobial agents and chemotherapy · 2022Review
- Isavuconazole for COVID-19-Associated Invasive Mold Infections.Journal of fungi (Basel, Switzerland) · 2022Review
- Fine Particulate Matter Exposure Levels in Patients with Normal-Tension Glaucoma and Primary Open-Angle Glaucoma: A Population-Based Study from Taiwan.International journal of environmental research and public health · 2022Article
- A Visual and Comprehensive Review on COVID-19-Associated Pulmonary Aspergillosis (CAPA).Journal of fungi (Basel, Switzerland) · 2021Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis analysis evaluated the variability of isavuconazole plasma concentrations between subjects and between sampling times, and assessed their relationship to outcomes for subjects with invasive fungal disease (IFD) in the SECURE trial.
methodsIsavuconazole-treated subjects received 372 mg of isavuconazonium sulphate (corresponding to 200 mg of isavuconazole) three times daily for 2 days, then once daily. Plasma samples were collected after day 4 and analysis sets were constructed as follows: analysis set 1 included all samples from subjects with proven/probable/possible IFD who received ≥1 dose of isavuconazole; analysis set 2 included samples from subjects in analysis set 1 who had provided >1 sample; and analysis set 3 included samples from subjects in analysis set 1 with proven/probable invasive aspergillosis. Assessments included overall distributions of plasma concentrations and variability between samples (analysis sets 1 and 2) as well as relationships to outcomes [all-cause mortality (day 42), overall response (end of treatment) and treatment-emergent adverse events; analysis sets 1 and 3].
resultsAnalysis sets 1, 2 and 3 included samples from 160, 97 and 98 subjects, respectively. Trough concentrations for each were distributed similarly [mean (SD): 3406.6 (1511.5), 3495.6 (1503.3) and 3368.1 (1523.2) ng/mL, respectively]. The mean coefficient of variation between samples in analysis set 2 was 23.2%; differences between concentrations in first samples and subsequent samples were <2-fold for 85/97 subjects. In quartiles of subject data, no concentration-dependent relationships were observed for efficacy or safety.
conclusionsPlasma concentrations of isavuconazole were reasonably consistent between subjects and sampling times, and were not associated with differences in outcomes.
Indexed as
Identifiers
What OpenQuestion holds
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.