Trial reportThe Journal of antimicrobial chemotherapy2020
Implications for IV posaconazole dosing in the era of obesity.
Trial report in The Journal of antimicrobial chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03246386 (Pharmacokinetics of Posaconazole Given as a Single Intravenous Dose to Obese Subjects), which is not on this map. Cited by 12 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.
Pharmacokinetics of Posaconazole Given as a Single Intravenous Dose to Obese Subjects: Dosing Obese With Noxafil® Under a Trial (DONUT)
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Guideline
- The effect of BMI on survival outcome of breast cancer patients: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Pooled it
- Risk Factors for Subtherapeutic Exposure and Hepatotoxicity Threshold of Posaconazole: A Real-World Study in Chinese Patients with Invasive Pulmonary Fungal Infection.Infection and drug resistance · 2026Article
- A Physiologically-Based Pharmacokinetic Model to Predict Posaconazole Suspension Exposure and Optimize Dosing Strategy in Pediatric Hematology Patients: Incorporating the Impact of Food Intake.Drug design, development and therapy · 2026Article
- Physiologically-based pharmacokinetic model for predicting drug-drug interactions perpetrated by posaconazole in healthy subjects with normal weight and obesity: Concomitant use and washout.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Approaches for posaconazole therapeutic drug monitoring and their clinical benefits.European journal of clinical pharmacology · 2024Review
- Patients with Obesity Should be Recognised as a Special Patient Population During Drug Development of Antibacterial and Antifungal Agents; A Call to Action.Clinical pharmacokinetics · 2024Article
- Incomplete Data and Potential Risks of Drugs in People with Obesity.Current obesity reports · 2023Review
- External evaluation of published population pharmacokinetic models of posaconazole.Frontiers in pharmacology · 2022Article
- A Review of Population Pharmacokinetic Models of Posaconazole.Drug design, development and therapy · 2022Review
- Taskforce report on the diagnosis and clinical management of COVID-19 associated pulmonary aspergillosis.Intensive care medicine · 2021Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe prevalence of obesity has shown a dramatic increase over recent decades. Obesity is associated with underdosing of antimicrobial drugs for prophylaxis and treatment. Posaconazole is a broad-spectrum triazole antifungal drug licensed for prophylaxis and treatment of invasive fungal infections. It is unclear how posaconazole should be dosed in obese patients.
methodsWe performed a prospective study investigating the pharmacokinetics of posaconazole in morbidly obese (n = 16) and normal-weight (n = 8) subjects, with a weight ranging between 61.4 and 190 kg, after a 300 or 400 mg IV dose. Population pharmacokinetic modelling was used to assess the effect of body size on posaconazole pharmacokinetics. ClinicalTrials.gov Identifier: NCT03246386.
resultsTotal body weight best predicted changes in CL and V. Model-based simulations demonstrated that, for treatment of fungal infections, a daily IV dose of 300 mg will result in a PTA of ≥90% in individuals up to 140 kg, after which both twice daily loading and the daily maintenance dose should be increased to 400 mg. For prophylaxis, a 300 mg IV dose is adequate in patients up to 190 kg.
conclusionsBody size has a significant impact on posaconazole CL and V, resulting in a lower exposure in obese subjects compared with normal-weight subjects. For therapeutic use of posaconazole, a dose increase is required in patients above 140 kg. For prophylaxis, a 300 mg IV dose is adequate. For oral treatment, these recommendations can act as a starting point followed by therapeutic drug monitoring.
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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.