{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T23:46:43Z","timestamp":1744069603835,"version":"3.37.3"},"reference-count":20,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2023,8,7]],"date-time":"2023-08-07T00:00:00Z","timestamp":1691366400000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Lupin Pharmaceuticals, Inc.","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoniasis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Post hoc analysis of data from a phase 3 randomised, double-blind, placebo-controlled, delayed-treatment study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>10 centres in the USA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Subgroup of women (aged \u226512 years) with a confirmed diagnosis of<jats:italic>Trichomonas vaginalis<\/jats:italic>and co-infection with BV clinically diagnosed using Amsel\u2019s criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Intervention<\/jats:title><jats:p>Single dose of secnidazole 2 g or placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Outcome measures<\/jats:title><jats:p>The primary efficacy outcome was the microbiological cure (negative culture for<jats:italic>T. vaginalis<\/jats:italic>) at the test of cure (TOC) visit 6\u201312 days after dosing in the modified intent-to-treat population (mITT). At TOC, participants received the opposite treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 131<jats:italic>T<\/jats:italic>.<jats:italic>vaginalis<\/jats:italic>-infected participants in the mITT, 79 (60.3%) met \u22653 Amsel\u2019s criteria for BV at enrolment. Microbiological cure rates for trichomoniasis at TOC among this subgroup of women were 97.7% (42\/43) for secnidazole and 0% (0\/36) for placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Single-dose oral secnidazole 2 g was highly efficacious in curing trichomoniasis in women co-infected with BV. Appropriate and effective treatment options for co-infection are essential for reducing transmission and reinfection. Secnidazole is the only single-dose medication approved by the Food and Drug Administration for the treatment of BV in women and trichomoniasis in women and men.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>ClinicalTrials.gov,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03935217\">NCT03935217; post-results<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-072071","type":"journal-article","created":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T03:34:06Z","timestamp":1707968046000},"page":"e072071","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"isrctn03935217","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4005-3858","authenticated-orcid":false,"given":"Christina A","family":"Muzny","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivia T","family":"Van Gerwen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory","family":"Kaufman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Chavoustie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,8,7]]},"reference":[{"key":"2024020708322537000_13.8.e072071.1","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181d36bdc"},{"key":"2024020708322537000_13.8.e072071.2","doi-asserted-by":"crossref","unstructured":"Bradshaw CS , Walker J , Fairley CK , et al . Prevalent and incident bacterial vaginosis are associated with sexual and contraceptive behaviours in young Australian women. PLoS One 2013;8:e57688. doi:10.1371\/journal.pone.0057688","DOI":"10.1371\/journal.pone.0057688"},{"key":"2024020708322537000_13.8.e072071.3","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.3428"},{"key":"2024020708322537000_13.8.e072071.4","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e318074e565"},{"key":"2024020708322537000_13.8.e072071.5","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr7005a1"},{"key":"2024020708322537000_13.8.e072071.6","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000972"},{"key":"2024020708322537000_13.8.e072071.7","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181f22f56"},{"key":"2024020708322537000_13.8.e072071.8","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2010.046441"},{"key":"2024020708322537000_13.8.e072071.9","doi-asserted-by":"publisher","DOI":"10.1007\/s11908-013-0325-5"},{"key":"2024020708322537000_13.8.e072071.10","doi-asserted-by":"crossref","first-page":"e192","DOI":"10.1097\/OLQ.0000000000001537","article-title":"Bacterial Vaginosis and its association with incident Trichomonas vaginalis infections: A systematic review and meta-analysis","volume":"48","author":"Se\u00f1a","year":"2021","journal-title":"Sex Transm Dis"},{"key":"2024020708322537000_13.8.e072071.11","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1097\/AOG.0000000000003604","article-title":"Vaginitis in Nonpregnant patients","volume":"135","year":"2020","journal-title":"Obstetrics & Gynecology"},{"key":"2024020708322537000_13.8.e072071.12","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(18):30423-7"},{"key":"2024020708322537000_13.8.e072071.13","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1080\/14787210.2022.2080656","article-title":"Secnidazole: a treatment for trichomoniasis in adolescents and adults","volume":"20","author":"Muzny","year":"2022","journal-title":"Expert Rev Anti Infect Ther"},{"key":"2024020708322537000_13.8.e072071.14","doi-asserted-by":"crossref","first-page":"e1282","DOI":"10.1093\/cid\/ciab242","article-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","volume":"73","author":"Muzny","year":"2021","journal-title":"Clin Infect Dis"},{"key":"2024020708322537000_13.8.e072071.15","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000968"},{"key":"2024020708322537000_13.8.e072071.16","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr6404a1"},{"key":"2024020708322537000_13.8.e072071.17","doi-asserted-by":"crossref","first-page":"e57","DOI":"10.1097\/OLQ.0000000000000959","article-title":"Is it time to stop using single-dose oral metronidazole for the treatment of trichomoniasis in women?","volume":"46","author":"Muzny","year":"2019","journal-title":"Sex Transm Dis"},{"key":"2024020708322537000_13.8.e072071.18","doi-asserted-by":"publisher","DOI":"10.1097\/01.olq.0000135990.21755.51"},{"key":"2024020708322537000_13.8.e072071.19","unstructured":"Lupin Pharmaceuticals Inc . 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