Secnidazole demonstrates therapeutic potential in bacterial vaginosis
Oral granules containing 1 and 2 g secnidazole outperform placebo in the treatment of bacterial vaginosis, according to the results of a phase II trial.
A total of 215 women with bacterial vaginosis were randomized to receive either secnidazole at a dose of 1 or 2 mg or placebo. All met the Amsel criteria of a discharge, pH of ≥4.7, clue cells ≥20 percent and positive whiff test.
The primary endpoint was clinical cure (normalization of discharge, amine odour and clue cells) after 21 to 30 days of treatment. Secondary endpoints were microbiologic cure (defined as a Nugent score of 0 to 3) and therapeutic cure (defined as meeting criteria for both clinical and microbiologic cure).
Of the patients who were initially randomized, only 188 (median age 33 years; 32 percent with ≥4 bacterial vaginosis episodes in the previous year) were included in the intent-to-treat population, with 62 each in the secnidazole 1 and 2 g arms and 64 in the placebo arm.
The respective clinical, microbiologic and therapeutic cure rates were 67.7, 40.3 and 40.3 percent with 2 g secnidazole and 51.6, 23.4 and 21.9 percent with the 1 g dose compared with 17.7, 6.5 and 6.5 percent with placebo (p<0.05 for all endpoints). Both secnidazole doses were well tolerated.
Researchers noted that while both dose levels were superior to placebo, the study was not powered to detect differences between the two secnidazole treatment groups.
The present finding, which demonstrates the potential of secnidazole in women with bacterial vaginosis, supports the further development of the drug for the treatment of this population. Additional studies evaluating single-dose 2-g secnidazole oral granules against an active comparator such as metronidazole are needed in order to better understand how a single-dose treatment may compare with a multidose regimen, researchers said.
Bacterial vaginosis is a disease characterized by a decline in the concentration of lactobacilli and an overgrowth of other microorganisms, particularly anaerobic and gram-negative species. The most commonly detected species are Gardnerella vaginalis, Prevotella species, Porphyromonas species, Bacteroides species, Peptostreptococcus species, Mycoplasma hominis, Ureaplasma urealyticum, Mobiluncus species, Fusobacterium species and Atopobium vaginae. [J Med Life 2013;6:434–436]
Currently recommended treatments for bacterial vaginosis include multidose oral and vaginal formulations of metronidazole and clindamycin. Oral formulations of tinidazole or clindamycin and intravaginal formulations of clindamycin and metronidazole are also used as alternative regimens. [MMWR Recomm Rep 2015;64:1–137; Infect Dis Obstet Gynecol 2005;13:155–60; Sex Transm Dis 2015;42:376–81]