Background Trichomoniasis is the most prevalent non-viral sexually transmitted disease and there is a clear need for identifying oral therapies that are effective against 5-nitroimidazole-resistant T. vaginalis (TV) infections. A randomised, double-blind, double-dummy, parallel group pivotal study was carried out to assess the efficacy and safety of a 7-day oral treatment course with nifuratel in comparison with metronidazole in women with trichomoniasis infection.
Methods Four-hundred-thirty-one patients, aged ≥ 18 years, were enrolled after providing their written informed consent. Women with a positive TV wet-mount microscopy were randomised and the diagnosis was confirmed by the InPouchTM TV culture method 3 days after. They received one tablet of nifuratel 200mg or metronidazole 250mg and one tablet of the corresponding placebo of the comparator three times daily after meals for 7 days. The TV eradication rate was assessed on day 21 ± 3 after the first drug intake. The concomitant infection by candidosis and the vulvovaginal signs and symptoms were also evaluated.
The non-inferiority of nifuratel compared to metronidazole at the pre-specified margin of Δ-10% was defined as the clinically acceptable difference between the two active treatments.
Results The TV eradication was achieved by the 95.9% of patients in the per protocol data set: 95.2% and 96.5% in the nifuratel and metronidazole group, respectively (p = 0.0062). The eradication rate of vulvovaginal candidosis after treatment with nifuratel or metronidazole was 53.6% vs. 45.8%. A similar decrease in vaginal signs and symptoms, such as edoema, erythema, colpitis, cervicitis, itching, burning and dysuria, was detected in both groups. The treatments were also well tolerated with a comparable safety profile.
Conclusion The trial proved that nifuratel 600 mg/day, minimum recommended daily dosage, is effective as metronidazole 750mg/day, average dosage recommended, in the treatment of trichomoniasis infection and suggests that nifuratel could still be an efficient alternative to metronidazole as first-line treatment.