Kissinger P, et al. - In this multicenter, open-label, randomized, controlled trial, researchers compared single-dose metronidazole to a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women; they also examined whether effectiveness was modified by bacterial vaginosis. According to findings, the authors indicated that the 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women.

Methods

• Study participants were enrolled at three US sexual health clinics.
• Women tested positive for Trichomonas vaginalis infection upon clinical screening were included in the analysis.
• Participants were randomized (1:1) to receive either a single dose of 2-g metronidazole (single-dose group) or 500 mg of metronidazole twice daily for 7 days (7-day dose group).
• The primary outcome was T. vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment.
• Analysis of the primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status.

Results

• Of 1,028 participants evaluated for eligibility, 623 women were randomized to treatment groups (311 women to the single-dose group and 312 women to the 7-day-dose group; intention-to-treat population).
• The investigation ended early due to funding limitations, although planned enrollment had been 1,664 women.
• Compared with patients in the single-dose group, those in the 7-day dose group were less likely to be T. vaginalis-positive at test-of-cure.
• They noted that bacterial vaginosis status had no significant impact on relative risk.
• Findings revealed that self-reported adherence was 96% in the 7-day-dose group and 99% in the single-dose group.
• Side-effects were comparable by group; nausea, followed by headache and vomiting were the most common side-effects.