Comparing 500 mg and 1000 mg Ceftriaxone Doses for Treating Uncomplicated Gonorrhea Infection in Men A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the treatment effects of two different doses of ceftriaxone for uncomplicated gonorrhea infection in men. This phase 3 randomized controlled trial aims to determine whether a 500-mg dose is not inferior to a 1000-mg dose in treating this infection, helping to inform optimal dosing strategies. The study is sponsored by National Taiwan University Hospital and focuses on men with confirmed gonorrhea infections in various anatomical sites. Participants receive a single intramuscular injection of either 500 mg or 1000 mg ceftriaxone, both dissolved in lidocaine solution, as part of a parallel-group design. The study compares these two treatment groups over a 14-day period following enrollment to assess treatment response and other outcomes. There is no masking, and participants receive only one dose during the study. During the study, participants are monitored from enrollment through 14 days after treatment. Researchers assess treatment response, symptom duration, and any adverse events related to the treatment. Laboratory tests include measuring the minimum inhibitory concentration of ceftriaxone on bacterial isolates, genetic typing of Neisseria gonorrhoeae, and gene mutations related to drug resistance. The total participation period is about two weeks, during which safety and effectiveness are closely tracked.

500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection