{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:11:00Z","timestamp":1792069860382,"version":"4.4.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,3,26]],"date-time":"2021-03-26T00:00:00Z","timestamp":1616716800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Lupin Pharmaceuticals, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,9,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6\u201312 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N\u2005=\u2005100) provided approximately 95% power to detect a statistically significant difference between treatment groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%\u201397.4%] vs 1.5% [95% CI: .0%\u20138.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%\u201398.9%] vs 1.7% [95% CI: .0%\u20138.9%]). Cure rates were 100% (4\/4) in women with human immunodeficiency virus (HIV) and 95.2% (20\/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and\/or BV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trials Registration<\/jats:title><jats:p>NCT03935217.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciab242","type":"journal-article","created":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T20:36:34Z","timestamp":1615926994000},"page":"e1282-e1289","source":"Crossref","is-referenced-by-count":40,"title":["Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study"],"prefix":"10.1093","volume":"73","author":[{"given":"Christina A","family":"Muzny","sequence":"first","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane R","family":"Schwebke","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Nyirjesy","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Lupin Pharmaceuticals, Inc, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leandro A","family":"Mena","sequence":"additional","affiliation":[{"name":"University of Mississippi Medical Center, Jackson, Mississippi, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gweneth B","family":"Lazenby","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina, Charleston, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia T","family":"Van Gerwen","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keonte J","family":"Graves","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janeen","family":"Arbuckle","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Belvia A","family":"Carter","sequence":"additional","affiliation":[{"name":"Women\u2019s Physician Group, Memphis, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Connette P","family":"McMahon","sequence":"additional","affiliation":[{"name":"Jones Center for Women\u2019s Health, Fayetteville, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Eder","sequence":"additional","affiliation":[{"name":"Center for Women\u2019s Health and Wellness, Lawrenceville, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackie","family":"Shaw","sequence":"additional","affiliation":[{"name":"Lupin Pharmaceuticals, Inc, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brajesh","family":"Pandey","sequence":"additional","affiliation":[{"name":"Lupin Pharmaceuticals, Inc, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven E","family":"Chavoustie","sequence":"additional","affiliation":[{"name":"Segal Trials for 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