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 ant imicrobial agent for use in treating uncomplicated gonococcal urethrit is. Ceftibuten is an orally active third-generation cephalosporin with potent in vitro activity against Neisseria gonorrhoeae. Its pharmacok inetic properties allow single-dose administration. Objective: To eval uate the efficacy, safety, and tolerability of ceftibuten in the treat ment of uncomplicated gonorrhea in men. Study Design: Ceftibuten was e valuated in an open-label, noncomparative, multicenter study. Eligible men with uncomplicated gonococcal urethritis were treated with a sing le 400-mg oral dose of ceftibuten and reassessed 1 week and 3 weeks af ter treatment. The main outcome measures were the isolation of N. gono rrhoeae, 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 r ate was 98.2% (110 of 112 evaluable patients), Adverse events, which o ccurred in 4.5% of patients, were all mild, well tolerated, and of sho rt duration. No significant changes in laboratory test results were no ted. Of the 125 isolates, 4.8% were -lactamase positive, Susceptibilit y 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. C onclusions: A single 400-mg oral dose of ceftibuten is highly effectiv e and well tolerated in the treatment of uncomplicated gonococcal uret hritis in men.