{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T09:02:12Z","timestamp":1790413332336,"version":"4.1.0"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,1,29]],"date-time":"2024-01-29T00:00:00Z","timestamp":1706486400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Mayne Pharma"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eighty-eight patients were enrolled for IFD (SUBA-itra, n = 42; c-itra, n = 46) caused by Histoplasma (n = 51), Blastomyces (n = 18), Coccidioides (n = 13), or Sporothrix (n = 6). On day 42, clinical success was observed with SUBA-itra and c-itra on day 42 (in 69% and 67%, respectively, and on day 180 (in 60% and 65%). Patients treated with SUBA-itra exhibited less drug-level variability at days 7 (P = .03) and 14 (P = .06) of randomized treatment. The concentrations of itraconazole and hydroxyitraconazole were comparable between the 2 medications (P = .77 and P = .80, respectively). There was a trend for fewer adverse events (AEs; 74% vs 87%, respectively; P = .18) and serious AEs (10% vs 26%; P = .06) in the SUBA-itra\u2013treated patients than in those receiving c-itra. Serious treatment-emergent AEs were less common in SUBA-itra\u2013treated patients (12% vs 50%, respectively; P &amp;lt; .001).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SUBA-itra was bioequivalent, well tolerated, and efficacious in treating endemic fungi, with a more favorable safety profile than c-itra.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT03572049.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofae010","type":"journal-article","created":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T16:15:26Z","timestamp":1704730526000},"source":"Crossref","is-referenced-by-count":20,"title":["MSG-15: Super-Bioavailability Itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses\u2014A Multicenter, Open-Label, Randomized Comparative Trial"],"prefix":"10.1093","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7612-4710","authenticated-orcid":false,"given":"Andrej","family":"Spec","sequence":"first","affiliation":[{"name":"Division of Infectious Disease, Washington University in St Louis School of Medicine , St Louis, Missouri , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George R","family":"Thompson","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Infectious Diseases and Department of Medical Microbiology and Immunology, University of California Davis Medical Center , Sacramento, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3175-0512","authenticated-orcid":false,"given":"Marisa H","family":"Miceli","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Infectious Disease, 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, Panama City , Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Mullane","sequence":"additional","affiliation":[{"name":"Department of Medicine\/Section of Infectious Diseases and Global Health, University of Chicago , Chicago, Illinois , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo-Ann","family":"Young","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Disease and International Medicine, Program in Adult Transplant Infectious Disease, University of Minnesota , Minneapolis, Minnesota , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald","family":"McGwin","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Infectious Diseases, University of Alabama at Birmingham , Birmingham, Alabama , 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