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.


METHODS
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.
Chong
L Y
LY
Social Hygiene Service, Department of Health, Kowloon, Hong Kong.
Cheung
W M
WM
Leung
C S
CS
Yu
C W
CW
Chan
L Y
LY
D000293:Adolescent; D000328:Adult; D000368:Aged; D000077722:Ceftibuten; D002511:Cephalosporins / Q000627:therapeutic use*; D004352:Drug Resistance, Microbial; D006069:Gonorrhea / Q000188:drug therapy*; D006723:Hong Kong; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D014526:Urethritis / Q000188:drug therapy* / Q000382:microbiology
D002511:Cephalosporins; D000077722:Ceftibuten