{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:58:45Z","timestamp":1791921525977,"version":"4.3.4"},"reference-count":25,"publisher":"American Society for Microbiology","issue":"1","license":[{"start":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T00:00:00Z","timestamp":1704844800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T00:00:00Z","timestamp":1704844800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Jiangsu Hengrui Pharmaceuticals","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2024,1,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Vulvovaginal candidiasis (VVC) is a common condition among women. Fluconazole remains the dominant treatment option for VVC. Oteseconazole is a highly selective inhibitor of fungal CYP51. This randomized, double-blinded, phase 3 trial was conducted to evaluate the efficacy and safety of oteseconazole compared with fluconazole in treating severe VVC. Female subjects presenting with vulvovaginal signs and symptoms score of \u22657 and positive\n            <jats:italic>Candida<\/jats:italic>\n            infection determined by potassium hydroxide test or Gram staining were randomly assigned to receive oteseconazole (600 mg on D1 and 450 mg on D2) or fluconazole (150 mg on D1 and D4) in a 1:1 ratio. The primary endpoint was the proportion of subjects achieving therapeutic cure [defined as achieving both clinical cure (absence of signs and symptoms of VVC) and mycological cure (negative culture of\n            <jats:italic>Candida<\/jats:italic>\n            species)] at D28. A total of 322 subjects were randomized and 321 subjects were treated. At D28, a statistically significantly higher proportion of subjects achieved therapeutic cure in the oteseconazole group than in the fluconazole group (66.88% vs 45.91%;\n            <jats:italic>P<\/jats:italic>\n            = 0.0002). Oteseconazole treatment resulted in an increased proportion of subjects achieving mycological cure (82.50% vs 59.12%;\n            <jats:italic>P<\/jats:italic>\n            &lt; 0.0001) and clinical cure (71.25% vs 55.97%;\n            <jats:italic>P<\/jats:italic>\n            = 0.0046) compared with fluconazole. The incidence of treatment-emergent adverse events was similar between the two groups. No subjects discontinued study treatment or withdrew study due to adverse events. Oteseconazole showed statistically significant and clinically meaningful superiority over fluconazole for the treatment of severe VVC and was generally tolerated.\n          <\/jats:p>","DOI":"10.1128\/aac.00778-23","type":"journal-article","created":{"date-parts":[[2023,12,14]],"date-time":"2023-12-14T14:02:23Z","timestamp":1702562543000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":30,"title":["Oteseconazole versus fluconazole for the treatment of severe vulvovaginal candidiasis: a multicenter, randomized, double-blinded, phase 3 trial"],"prefix":"10.1128","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-3288-544X","authenticated-orcid":false,"given":"Xiaoqian","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, Tsinghua University School of Clinical Medicine , Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lihong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Shaanxi Provincial People\u2019s Hospital , Shaanxi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongjie","family":"Ruan","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Women\u2019s Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital , Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengai","family":"Xiong","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Chongqing Medical University , Chongqing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenying","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, The First Affiliated Hospital of Xi\u2019an Medical University , Shaanxi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Shanghai Tong Ren Hospital, Shanghai Jiaotong University School of Medicine , Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihua","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Obstetrics Women &amp; Children\u2019s Health Care Hospital of Linyi , Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunlian","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Taihe Hospital Affiliated Hospital of Hubei University of Medicine , Hubei, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengxia","family":"Xue","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Tianjin Medical University General Hospital , Tianjin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianhua","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Urumqi Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region , Xinjiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Xuzhou Central Hospital , Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruifang","family":"An","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi\u2019an Jiaotong University , Shaanxi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiping","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Guangdong Women and Children Hospital , Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Peking University Third Hospital , Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Songling","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The First Hospital of Jilin University , Jilin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunlang","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University , Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiali","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Guangzhou First People\u2019s Hospital , Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henan","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Gynecology, The First People\u2019s Hospital of Chenzhou , Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shangrong","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital , Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manhua","family":"Cui","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The Second Hospital of Jilin University , Jilin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shijin","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, The First Affiliated Hospital of Xinxiang Medical University , Henan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaowan","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Boai Hospital of Zhongshan , Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiying","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Women and Children\u2019s Hospital of Xiamen University , Fujian, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Shu","sequence":"additional","affiliation":[{"name":"Department of Reproductive Endocrinology and Gynecology, Zhejiang Provincial People\u2019s Hospital , Zhejiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quanren","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd. , Shanghai, 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