S4.5b A randomized, double blind phase II proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus itraconazole 400 mg daily, all three arms in combination with surgery, in patients with eumycetoma in Sudan—pharmacokinetic results
Abstract
Abstract S4.5 Mycetoma Clinical Trial on fosravuconazole treatment in eumycetoma– Top Line Results, September 22, 2022, 10:30 AM - 12:00 PM Objective To evaluate the pharmacokinetics (PK) of fosravuconazole (measured as ravuconazole) and itraconazole in patients with mild to moderate eumycetoma caused by Madurella mycetomatis using a non-compartmental PK analysis. Methods Participants received either 200 mg or 300 mg ravuconazole once weekly or 400 mg itraconazole daily for a total duration of 12 months. Plasma concentrations of ravuconazole and itraconazole were measured on day 1 of week 1, and on weeks 2, 3, 4, and months 2, 3, 6, and 12 (at end of treatment) for analysis of population PK. The exact time of dosing on the days of sample collection, and the exact time of sample collection within the collection time window, were recorded. Plasma concentrations were quantified using Ultraperformance Liquid Chromatography with fluorescence detection (UPLC-UV). Ravuconazole and itraconazole plasma concentration-time data was performed using a standard two stage approach with non-compartmental analysis. Derived exposure parameters of ravuconazole and itraconazole, including, but not limited to, Cmax and AUC at steady state (AUCs), were calculated. The effect of covariates, such as baseline characteristics/demographics, on PK were explored. AUCs were determined when at least three subsequent samples within one dosing interval were available. Results A total of 766 samples of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 68 participants or records.
Read the paper
Related studies
- Diagnosis and management of glutaric aciduria type I – revised recommendations
- EZH2 Codon 641 Mutations are Common in BCL2-Rearranged Germinal Center B Cell Lymphomas
- Consensus guidelines for the diagnosis and management of pyridoxine‐dependent epilepsy due to α‐aminoadipic semialdehyde dehydrogenase deficiency
- Systemic Metabolomic Changes in Blood Samples of Lung Cancer Patients Identified by Gas Chromatography Time-of-Flight Mass Spectrometry
- Human OTULIN haploinsufficiency impairs cell-intrinsic immunity to staphylococcal α-toxin
- Discovery of Novel Recurrent Mutations in Childhood Early T-Cell Precursor Acute Lymphoblastic Leukemia by Whole Genome Sequencing - a Report From the St Jude Children's Research Hospital - Washington University Pediatric Cancer Genome Project
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.