Comparative Double-Blind Multicentre Study of Single-Dose Pefloxacin and Amoxicillin Plus Probenecid for Treatment of Acute Uncomplicated Gonorrhoea
In a double-blind, randomised multicentre study, 129 patients (92 males, 37 females) with culture proven acute uncomplicated genital gonorrhoea were given single oral doses of either Pefloxacin 800mg (n = 65) or amoxicillin 3.0g plus probenecid 1.0g (n = 64). Data from 36 patients (19 Pefloxacin and 17 amoxicillin plus probenecid) were not évaluable. All 146 strains of Neisseria gonorrhoeae isolated from evaluable patients were sensitive to Pefloxacin whereas 139 of 146 were sensitive to penicillin (statistically significant at p < 0.05, binomial test).
84% of gonococcal infections involved only a genital site whereas implication of other sites was observed in 11% of patients; 4% of the patients were asymptomatic carriers of infected participants. Cure (negative post-treatment culture) rates were 100% (65/65) in pefloxacin-treated patients and 94% (60/64) in the amoxicillin plus probenecid group: the 4 treatment failures were 3 men with positive N. gonorrhoeae urethral cultures and a woman with a positive throat culture. Postgonococcal urethritis was observed in 9 pefloxacin and 4 amoxicillin plus probenecid-treated patients. 18% of pefloxacin-treated patients and 15% of amoxicillin plus probenecid-treated patients presented drug-related adverse events consisting mainly of gastrointestinal (nausea, diarrhoea) or CNS (headache) disturbances of mild intensity. Two amoxicillin plus probenecid patients presented post-treatment Candida albicans vaginitis requiring antifungal therapy. In conclusion, results from this study indicate that a single oral 800mg dose of Pefloxacin can be considered as well tolerated and as effective as the amoxicillin plus probenecid combination for the treatment of acute uncomplicated gonorrhoea.
KeywordsAmoxicillin Probenecid Chlamydia Trachomatis Pefloxacin Neisseria Gonorrhoeae
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