Objectives
SYM-1219, a granule formulation of secnidazole, a 5-nitroimidazole with a longer half-life (∼17 hr) than metronidazole (∼8 hr), is being developed to treat bacterial vaginosis (BV). Secnidazole has been used outside the US to treat protozoal and anaerobic infections. The objectives of this study were to compare the efficacy and safety of SYM-1219 granules containing 1 or 2 grams of secnidazole to placebo for the treatment of women with BV.
Methods
215 women who met the 4 Amsel criteria for BV (discharge, pH ≥ 4.7, ≥ 20% clue cells, positive whiff test) were randomized 1:1:1 at 24 US sites to single oral doses of 1 or 2 g of secnidazole as SYM-1219 granules or placebo. A baseline vaginal smear was evaluated in a central laboratory for Nugent scoring (a score ≥ 4 was required for the study), and tests for sexually transmitted pathogens were obtained. Safety data included assessment of AEs, physical exam findings and laboratory results. Patients were evaluated for efficacy between days 21-30. The primary endpoint was clinical cure defined as a normal discharge, negative whiff test and clue cells < 20%. Microbiological cure was a Nugent score of 0-3 and therapeutic cure was both clinical and microbiological cure. The modified Intention-to-Treat (mITT) population was used for the efficacy analyses. All statistical comparisons used a stratified Cochran-Mantel-Haenszel (CMH) test performed at a 0.05 level of significance (2-sided).
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