Clinical Evaluation of Ceftibuten in Gonorrhea: A Pilot Study in Hong Kong

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Abstract

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 againstNeisseria 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 ofN. 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.

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