In the current study, researchers evaluated the efficacy and safety of secnidazole vs. placebo in women with trichomoniasis.
The study design consisted of Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2g 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 ~95% power to detect a statistically significant difference between treatment groups.
Data analysis revealed some interesting facts.
- Between April 2019 and March 2020, 147 women enrolled at 10 US sites. The modified intent-to-treat (mITT) population included 131 randomized patients (64/67, in secnidazole/placebo).
- Cure rates were significantly higher in the secnidazole vs. placebo group (92.2% [95% CI: 82.7–97.4] vs. 1.5% [95% CI: 0.0–8.0]) for the mITT population and for the per-protocol population (94.9% [95% CI: 85.9–98.9]) vs. 1.7% [95% CI: 0.0–8.9]).
- Cure rates were 100% (4/4) in women with 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.
"In conclusion, this study demonstrated that a single dose of SEC 2 g was efficacious and well tolerated in women with trichomoniasis and in those with trichomoniasis and comorbid HIV and/or BV. If approved by the FDA for the treatment of trichomoniasis, SEC will be the only single oral-dose medication available for the treatment of BV and T. vaginalis. Future studies should be considered in pregnant women and those with persistent T. vaginalis infection, including the use of SEC multi-dose regimens."The team concluded.
FOR FULL ARTICLE FOLLOW THE LINK: https://doi.org/10.1093/cid/ciab242
PRIMARY SOURCE: Clinical Infectious Diseases
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