Background and objectives: Antibiotic therapy for Neisseria gonorrhoeae infections has evolved owing to the development of resistance to penicillin and tetracycline therapy. A variety of antimicrobials, including the fluoroquinolones, have been proposed as useful alternatives.
Goal of the study: To evaluate the efficacy and safety of oral ciprofloxacin as single-dose treatment for urogenital and extragenital gonococcal infections.
Study design: 1180 patients with uncomplicated gonococcal infection received single-dose ciprofloxacin regimens ranging from 100 mg to 2000 mg to demonstrate microbiologic efficacy and to determine the minimum effective dose. Eight of 18 studies were randomized, controlled trials with ampicillin/probenecid, amoxicillin/probenecid, ceftriaxone, or spectinomycin as control drugs.
Results: Although a ciprofloxacin dose-response was not detected, 250 mg was used in most of the studies. Among 815 patients with 910 infected sites receiving 250 mg of ciprofloxacin, bacteriologic eradication was achieved in 563 (100%) male urethral, 199 (100%) female cervical, 101 (99%) male and female rectal, and 47 (96%) male and female pharyngeal sites.
Conclusion: Although the World Health Organization and the Centers for Disease Control and Prevention have identified 500 mg of ciprofloxacin as a single-dose treatment regimen for uncomplicated gonorrhea, the clinical data from the multinational studies indicate that a 250-mg single-dose of ciprofloxacin is equally effective in the management of uncomplicated gonorrhea, including extragenital sites of infection.
PIP: Between 1983 and 1990, an international review of 18 clinical trials was conducted to identify a single-dose regimen of ciprofloxacin that will attain at least a 95% efficacy rate for urogenital and extragenital uncomplicated Neisseria gonorrhoeae infections. The trials took place in the US, Argentina, the UK, Finland, Thailand, South Africa, Spain, Belgium, Poland, and the Netherlands. The studies consisted of 1180 patients who received a single-dose of 100-2000 mg ciprofloxacin. 8 studies compared the single-dose ciprofloxacin regimen with ampicillin/probenecid, amoxicillin/probenecid, ceftriaxone, or spectinomycin. 15 studies used, at least, a single-dose of 250 mg ciprofloxacin to treat 815 patients with 910 infected sites. This dose eradicated N. gonorrhoeae from 100% of male urethral, 100% of female cervical, 99% of male and female rectal, and 96% of male and female pharyngeal sites. In all 18 studies, ciprofloxacin was well tolerated. The leading side effects were headache and nausea. The wholesale cost of a single dose of 250 mg ciprofloxacin is lower than that of other antibiotics used to treat uncomplicated gonorrhea ($2.53 vs. $3.36 for 400 mg ofloxacin, $3.84 for 125 mg ceftriaxone, and $5.60 for 400 mg cefixime). Even though WHO and the US Centers for Disease Control recommend a single-dose of 500 mg ciprofloxacin to treat uncomplicated gonorrhea, the findings of the international studies suggest that a single dose of 250 mg ciprofloxacin effectively treats uncomplicated gonorrhea, even extragenital sites of infection.