University of Alabama at Birmingham, Birmingham, Alabama, USA.
Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Clin Infect Dis. 2021 Sep 15;73(6):e1282-e1289. doi: 10.1093/cid/ciab242.
Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis.
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 6-12 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 = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups.
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%-97.4%] vs 1.5% [95% CI: .0%-8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%-98.9%] vs 1.7% [95% CI: .0%-8.9%]). 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.
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.
NCT03935217.
阴道毛滴虫是最常见的非病毒性性传播感染。我们评估了单剂量口服 secnidazole 与安慰剂治疗滴虫病女性的疗效和安全性。
经阴道毛滴虫培养阳性确诊为滴虫病的女性随机分为单次口服 secnidazole 2 g 或安慰剂。主要终点是给药后 6-12 天的微生物学治愈测试（TOC）。在 TOC 就诊时，参与者接受相反的治疗。此后随访感染是否缓解，并在需要时在随后的就诊中提供治疗。每组 50 名患者（N=100）提供了约 95%的效力来检测治疗组之间的统计学显著差异。
2019 年 4 月至 2020 年 3 月，在美国 10 个地点招募了 147 名女性。修改后的意向治疗（mITT）人群包括 131 名随机患者（secnidazole，n=64；安慰剂，n=67）。secnidazole 组的治愈率显著高于安慰剂组，mITT 人群为 92.2%（95%置信区间[CI]：82.7%-97.4%）vs 1.5%（95%CI：0.0%-8.0%），和符合方案人群为 94.9%（95%CI：85.9%-98.9%）vs 1.7%（95%CI：0.0%-8.9%）。HIV 阳性的女性治愈率为 100%（4/4），BV 阳性的女性治愈率为 95.2%（20/21）。secnidazole 通常具有良好的耐受性。最常见的治疗后不良事件（TEAE）是外阴阴道念珠菌病和恶心（各 2.7%）。未观察到严重的 TEAEs。
单次口服 2 g secnidazole 与安慰剂相比，微生物学治愈率显著提高，支持 secnidazole 用于治疗滴虫病女性，包括 HIV 阳性和/或 BV 阳性的女性。
NCT03935217。
