Comparison of ciprofloxacin and ceftriaxone as single-dose therapy for uncomplicated gonorrhea in women

Abstract

Although women bear. the brunt of gonococcal infection-related morbidity, few large studies of gonorrhea treatment in women have been conducted. In a multicenter, double-blind, placebo-controlled trial, 181 evaluable women with uncomplicated gonorrhea were treated with ciprofloxacin (250 mg orally; 94 women) or ceftriaxone (250 mg intramuscularly; 87 women). Twenty-four percent of the participants were infected with antibiotic-resistant Neisseria gonorrhoeae. Cervical gonorrhea was cured in 100%o (93 of 93) of the women treated with ciprofloxacin and 99% (83 of 84) receiving ceftriaxone. All pharyngeal (n = 5) or rectal (n = 20) infections treated with ciprofloxacin were cured, as were ceftriaxone-treated patients with pharyngeal (n = 6) or rectal (n = 21) infection. Geometric mean MICs (range) for 248 pretreatment isolates were: penicillin, 0.28 (0.015 to 8.0); tetracycline, 0.46 (0.06 to 4); ciprofloxacin, 0.003 (0.002 to 0.015); and ceftriaxone, 0.004 (0.001 to 0.125) ,ug/ml. Both drugs were well tolerated. Despite the high prevalence of antibiotic-resistant gonococci in these populations, 250 mg of oral ciprofloxacin was as effective as an injection of ceftriaxone.Despite the more than 30% decline in gonorrhea cases reported in the decade of the 1980s, infections due to Neisseria gonorrhoeae continue to be the most common reportable bacterial disease in the United States (5). The proportion of isolates resistant to penicillin or tetracycline also has increased dramatically.Although not yet a major problem in the United States, development of resistance to alternative therapies such as spectinomycin or even the newer quinolones is a continuing concern (1, 5, 15). In addition, gonorrhea rates tend to be highest in Americans aged 15 to 24 years, but late consequences which disproportionately affect women (e.g., infertility, ectopic pregnancy) often do not become apparent until years after the acute infection. Paradoxically, while gonorrhea and its sequelae tend to most profoundly affect females, studies of gonorrhea therapy predominantly report data for men. To provide more data on the treatment of gonorrhea in women and on the utility of ciprGfloxacin, a currently recommended alternative to ceftriaxone for gonorrhea treatment, we conducted a prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing 250 mg of oral ciprofloxacin with 250 mg of intramuscular ceftriaxone for therapy of uncomplicated gonorrhea in women attending sexually transmitted disease (STD) clinics. MATERIALS AND METHODSStudy design. The study was a prospectively conducted, randomized, double-blind, placebo-controlled trial in which all participants received both an injection and a single oral dose of medication. All medications were administered by a third party who had been instructed not to inform the study * Corresponding author.clinician of the therapeutic regimen utilized. Patients randomized to ciprofloxacin therapy received one 250-mg tablet of ciprofloxacin orally and an injection of sterile 0.9% sodium c...

Pharmacologic management of sexually transmitted diseases

“…Infections due to Neisseria gonorrhoeae , a gram‐negative diplococcus, continue to be the most reportable communicable disease in the United States (48). Gonorrhea rates tend to be highest in Americans aged 15–24; however, late consequences, which disproportionately affect women (PID, infertility, ectopic pregnancy) may not become apparent until years after the acute infection (66).…”

Dose-ranging study of CP-99,219 (trovafloxacin) for treatment of uncomplicated gonorrhea

“…Specimens for N. gonorrhoeae isolation were inoculated onto modified Thayer-Martin medium and were cultured as described previously (5,10). ␤-Lactamase production was assessed by the chromogenic cephalosporin method.…”

“…Antibiotic MICs were determined by agar dilution in GCA agar base (Becton-Dickinson, Baltimore, Md.) containing 1% IsoVita-leX and doubling dilutions of antibiotics (5,10). High-level (TetM) plasmid-mediated tetracycline resistance was presumptively defined on the basis of tetracycline MICs of Ն16 mg/liter.…”

“…Isolates were considered to have chromosomally mediated resistance to tetracycline on the basis of MICs of 2.0 to 8.0 mg/liter or to penicillin if the isolate did not produce ␤-lactamase and MICs of penicillin were Ն2 mg/liter. C. trachomatis cell cultures were performed in microtiter plates as described previously (5).…”

Activities of three investigational fluoroquinolones (BAY y 3118, DU-6859a, and clinafloxacin) against Neisseria gonorrhoeae isolates with diminished susceptibilities to ciprofloxacin and ofloxacin

“…Their excellent in vitro activity, oral bioavailability, penetration into genitourinary fluids and tissues, safety, and efficacy and the convenience of a single oral dose have made them excellent choices for alternative therapy. Numerous studies have demonstrated their efficacy to be comparable to or better than that of ceftriaxone (2,10,14,15).…”