Safety and efficacy of WC2031 versus vibramycin for the treatment of uncomplicated urogenital Chlamydia trachomatis infection: a randomized, double-blind, double-dummy, active-controlled, multicenter trial

by Selleckchem | Apr 23 2023

Background: Recent studies have raised concern about efficacy of azithromycin for Chlamydia trachomatis infection. Research investigating new antibiotic regimens for chlamydia has been sparse, especially regimens that may reduce adherence difficulties with the recommended twice-daily doxycycline regimen.

Methods: We conducted a randomized, double-blind, double-dummy, active-controlled, multicenter trial with the objective of evaluating the safety and efficacy of WC2031 (doxycycline hyclate delayed-release 200-mg tablet) orally once daily for 7 days versus Vibramycin (doxycycline hyclate capsule) 100 mg orally twice daily for 7 days for treatment of uncomplicated urogenital chlamydia. Men and nonpregnant women aged 19-45 years with a urogenital chlamydial diagnosis or a sexual partner with chlamydia were eligible. The primary outcome was microbial cure by nucleic acid amplification testing at day 28. Noninferiority of WC2031 was inferred if the lower limit of the 95% confidence interval (CI) of the difference in cure rates was >-10%.

Results: A total of 495 subjects were randomized. The modified intent-to-treat (mITT) population with evaluable efficacy consisted of 323 subjects. Baseline patient characteristics did not differ between the mITT groups. Microbial cure rates for WC2031 were 95.5% (95% CI, 92.3-98.8) versus 95.2% (95% CI, 92.0-98.4) for Vibramycin (95% CI for the difference in cure rates, -4.3% to 4.9%). Types of adverse events were comparable. Nausea and vomiting occurred less frequently with WC2031 than with Vibramycin (13% vs 21% and 8% vs 12%, respectively).

Conclusions: WC2031 was noninferior to Vibramycin for uncomplicated urogenital chlamydia treatment, better tolerated, and demonstrated comparable safety. WC2031 could improve treatment adherence over twice-daily Vibramycin.

Comments：

The study described is a randomized, double-blind, double-dummy, active-controlled, multicenter trial designed to compare the safety and efficacy of WC2031, a once-daily, delayed-release formulation of doxycycline hyclate, versus Vibramycin, the currently recommended twice-daily doxycycline hyclate capsule, for the treatment of uncomplicated urogenital chlamydia. The trial enrolled 495 men and nonpregnant women aged 19-45 years with a urogenital chlamydial diagnosis or a sexual partner with chlamydia. The primary outcome was microbial cure at day 28, and the noninferiority of WC2031 was inferred if the lower limit of the 95% confidence interval of the difference in cure rates was greater than -10%.

The study found that WC2031 was noninferior to Vibramycin for the treatment of uncomplicated urogenital chlamydia, with microbial cure rates of 95.5% and 95.2%, respectively. The types of adverse events were comparable between the two groups, but nausea and vomiting occurred less frequently with WC2031 than with Vibramycin. The results suggest that WC2031 could improve treatment adherence over twice-daily Vibramycin and could be an alternative treatment option for uncomplicated urogenital chlamydia.