MSG-15: Super-Bioavailability Itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses-A Multicenter, Open-Label, Randomized Comparative Trial.
blastomycosis
coccidioidomycosis
endemic mycoses
histoplasmosis
itraconazole
Journal
Open forum infectious diseases
ISSN: 2328-8957
Titre abrégé: Open Forum Infect Dis
Pays: United States
ID NLM: 101637045
Informations de publication
Date de publication:
Mar 2024
Mar 2024
Historique:
received:
28
12
2023
accepted:
08
01
2024
medline:
5
3
2024
pubmed:
5
3
2024
entrez:
5
3
2024
Statut:
epublish
Résumé
Invasive fungal disease caused by dimorphic fungi is associated with significant morbidity and mortality. Super-bioavailability itraconazole (SUBA-itra) is a novel antifungal agent with pharmacokinetic advantages over currently available formulations. In this prospective comparative study, we report the outcomes of patients with endemic fungal infections (histoplasmosis, blastomycosis, coccidioidomycosis, and sporotrichosis). This open-label randomized trial evaluated the efficacy, safety, and pharmacokinetics SUBA-itra compared with conventional itraconazole (c-itra) treatment for endemic fungal infections. An independent data review committee determined responses on treatment days 42 and 180. Eighty-eight patients were enrolled for IFD (SUBA-itra, n = 42; c-itra, n = 46) caused by SUBA-itra was bioequivalent, well tolerated, and efficacious in treating endemic fungi, with a more favorable safety profile than c-itra. NCT03572049.
Sections du résumé
Background
UNASSIGNED
Invasive fungal disease caused by dimorphic fungi is associated with significant morbidity and mortality. Super-bioavailability itraconazole (SUBA-itra) is a novel antifungal agent with pharmacokinetic advantages over currently available formulations. In this prospective comparative study, we report the outcomes of patients with endemic fungal infections (histoplasmosis, blastomycosis, coccidioidomycosis, and sporotrichosis).
Methods
UNASSIGNED
This open-label randomized trial evaluated the efficacy, safety, and pharmacokinetics SUBA-itra compared with conventional itraconazole (c-itra) treatment for endemic fungal infections. An independent data review committee determined responses on treatment days 42 and 180.
Results
UNASSIGNED
Eighty-eight patients were enrolled for IFD (SUBA-itra, n = 42; c-itra, n = 46) caused by
Conclusions
UNASSIGNED
SUBA-itra was bioequivalent, well tolerated, and efficacious in treating endemic fungi, with a more favorable safety profile than c-itra.
Clinical Trials Registration
UNASSIGNED
NCT03572049.
Identifiants
pubmed: 38440302
doi: 10.1093/ofid/ofae010
pii: ofae010
pmc: PMC10911225
doi:
Banques de données
ClinicalTrials.gov
['NCT03572049']
Types de publication
Journal Article
Langues
eng
Pagination
ofae010Informations de copyright
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Déclaration de conflit d'intérêts
Potential conflicts of interest. A. S. reports research funding from Astellas and Mayne and consulting fees from GSK and F2G. As deputy editor for Open Forum Infectious Diseases, per journal policy, A. S. was not involved in the peer review or editorial decision process for this article. G. R. T. reports research support and consulting fees from Astellas, Cidara, F2G, Mayne, Melinta, Merck, and Scynexis and served as a consultant for Pfizer. M. H. M. has received research funding from Mayne, F2G, and Scynexis and consulting fees from Astellas, Scynexis, and PSI. J. H. reports research funding from Mayne. L. A. M. is an employee of Mayne Pharma. P. G. P reports research funding from Mayne, Astellas, Scynexis, Melinta, and Cidara and consulting fees from Matinas, Melinta, and F2G. All other authors report no potential conflicts.