JMIR Publications

ABSTRACT

Background:

Background:

Mycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. Current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant M. genitalium or strains with unknown resistance profiles. Whether sitafloxacin, a fourth-generation fluoroquinolone antibiotic, is effective against resistant strains.

Objective:

Objective:

We aimed to assess and compare the efficacy and safety of sitafloxacin and moxifloxacin-based treatment regimens for managing M. genitalium infections.

Methods:

Methods:

This randomized controlled trial will be conducted at multiple centers in Japan. Eligible participants are adults aged at least 18 years with a confirmed M. genitalium infection as determined by the nucleic acid amplification test (NAAT). Patients will be randomly assigned using a stratified approach based on the treatment facility and infection site. The interventions comprise oral sitafloxacin (200 mg) daily for 7 d (with optional pre-treatment of oral doxycycline (200 mg) daily for up to 7 d), and a control group receiving oral doxycycline (200 mg) daily for 7 d, followed by moxifloxacin (400 mg) daily for another 7 d. The primary outcome is the treatment success rate, as confirmed by the NAAT. Secondary outcomes encompass changes in bacterial load of urogenital or rectal site and the emergence of post-treatment resistant mutant strains.

Results:

Results:

Enrollment commenced in June 2023 and will conclude in December 2024, with findings anticipated by 2025. The expected success rates fall within the range of 80% for sitafloxacin and 42% for moxifloxacin against M. genitalium carrying the G248T(S83I) mutation based on previous studies. Accordingly, with a significance level of 5% (two-sided) and 80% statistical power, we aim to recruit 50 participants per group, factoring in a 10% expected dropout rate.

Conclusions:

Discussion: This study will provide valuable insights into the efficacy and safety of sitafloxacin- versus moxifloxacin-based sequential therapy in treating M. genitalium infections. These findings have the potential to influence clinical guidelines, favoring more effective therapeutic choices. The multicenter approach enhances the robustness of this study. One limitation is the potential insufficiency of statistical power to detect post-treatment resistant mutant strains in each group, rendering post-treatment resistance mutations a notable concern. In the future, we may need to increase sample size to enhance power. Clinical Trial: Trial Registration: Japan Registry of Clinical Trials (jRCTs031230111).