Clinical evaluation of ceftibuten in Gonorrhea - A pilot study in Hong Kong

Background: The escalating rates of gonococcal resistance to quinolone in Hong Kong have prompted a search for an alternative first-line antimicrobial agent for use in treating uncomplicated gonococcal urethritis. Ceftibuten is an orally active third-generation cephalosporin with potent in vitro activity against Neisseria gonorrhoeae. Its pharmacokinetic properties allow single-dose administration. Objective: To evaluate the efficacy, safety, and tolerability of ceftibuten in the treatment of uncomplicated gonorrhea in men. Study Design: Ceftibuten was evaluated in an open-label, noncomparative, multicenter study. Eligible men with uncomplicated gonococcal urethritis were treated with a single 400-mg oral dose of ceftibuten and reassessed 1 week and 3 weeks after treatment. The main outcome measures were the isolation of N. gonorrhoeae, patient-reported side effects, and other safety parameters (e.g., blood counts and renal and hepatic function tests). Results: One hundred twenty-five men were enrolled in the study. The overall cure rate was 98.2% (110 of 112 evaluable patients), Adverse events, which occurred in 4.5% of patients, were all mild, well tolerated, and of short duration. No significant changes in laboratory test results were noted. Of the 125 isolates, 4.8% were -lactamase positive, Susceptibility to ofloxacin was found to be low in 59.2 % of isolates (MIC 0.1 to <1g/mL) and 25.6% of isolates were resistant (MIC1g/mL) to ofloxacin. Conclusions: A single 400-mg oral dose of ceftibuten is highly effective and well tolerated in the treatment of uncomplicated gonococcal urethritis in men.