Randomized study of cefotaxime versus ceftriaxone for uncomplicated gonorrhea.

Cefotaxime is a third-generation cephalosporin with excellent in vitro antimicrobial activity against Neisseria gonorrhoeae, including beta-lactamase-producing strains. A single 1-g intramuscular dose is suitable for the treatment of uncomplicated gonorrhea. We conducted an open, randomized study to evaluate the efficacy, safety, and cost impact of a lower dose (500 mg) of cefotaxime versus 250 mg ceftriaxone, an often recommended treatment for uncomplicated gonorrhea. Of the 222 patients enrolled, the cases of 151 were fully assessable. Bacteriologic elimination rates were 99% in the cefotaxime group and 100% in the ceftriaxone group. Clinical response rates were 78% and 83% in the two groups, respectively. Adverse clinical events occurred in 4% and 9% of patients in the two groups, respectively. The average wholesale price of 500 mg cefotaxime is 31% lower than that of 250 mg ceftriaxone. A 500-mg dose of cefotaxime appears to be a safe and cost-effective alternative to 250 mg ceftriaxone for the treatment of uncomplicated gonorrhea.

Multicenter study of a single 500-mg dose of cefotaxime for treatment of uncomplicated gonorrhea.

One hundred thirty-seven evaluable patients with uncomplicated gonorrhea were treated with a single 500-mg intramuscular dose of cefotaxime. All isolates were susceptible to concentrations of cefotaxime less than or equal to 0.1 microgram/ml. The minimum concentration of cefotaxime needed to inhibit 90% of isolates was less than 0.04 microgram/ml. At follow-up, infection was eradicated in 181 of 187 (97%) infection sites. Bacteriologic cures of 100 of 101 (99%), 55 of 56 (98%), 23 of 25 (92%), and 3 of 5 (60%) were attained at the urethral, endocervical, rectal, and oropharyngeal sites, respectively. Side effects were minor, and 90% of patients rated the injection-site pain as absent or mild. A single 500-mg dose of cefotaxime is an effective, economic treatment for uncomplicated gonorrhea.

Randomized comparison of ofloxacin and doxycycline for chlamydia and ureaplasma urethritis and cervicitis.

Fifty-eight males and 34 females with nongonococcal urethritis and/or cervicitis were treated to compare the efficacy and safety of 7-day regimens of oral ofloxacin 300 mg twice daily and doxycycline hyclate 100 mg twice daily. Forty-seven patients were randomized to receive ofloxacin and 45 patients to receive doxycycline. The microbiologic response rate was 97% (32/33) for both ofloxacin and doxycycline; the combined microbiologic and clinical cure rates were 98% for both treatment groups (ofloxacin 46/47, doxycycline 44/45). Ofloxacin was as effective as doxycycline in the treatment of chlamydial infections (96% vs. 100%). In patients with Ureaplasma urealyticum, the initial response was complete with either drug, but recurrence of infection was observed with both treatment groups (1 of 4 patients in the ofloxacin group and 2 of 11 patients in the doxycycline group). In the treatment of mixed Chlamydia trachomatis and U. urealyticum infections, all 5 patients treated with ofloxacin and 3 of 4 patients treated with doxycycline were cured. In symptomatic patients whose initial cultures were negative, clinical cures were complete with both drugs, but Ureaplasma was isolated at 3 or more weeks post-treatment in 2 patients treated with ofloxacin. In a study of single-dose ofloxacin treatment of uncomplicated gonorrhea, Neisseria gonorrhoeae was eradicated in all subjects, but C. trachomatis was not reliably eradicated. Both drugs were well tolerated with only minimal adverse effects reported in either treatment group. A multiple-dose regimen of ofloxacin appears to be a highly effective and well-tolerated alternative to doxycycline in nongonococcal sexually transmitted disease.

Single-dose efficacy of ofloxacin in uncomplicated gonorrhea.

Two multicenter trials compared single-dose oral therapy with 400 mg of ofloxacin or 3 g of amoxicillin plus 1 g of probenecid in the treatment of uncomplicated gonorrhea in 160 men and 102 women. Patients with a known diagnosis of Chlamydia trachomatis infection were excluded. All pretreatment isolates of Neisseria gonorrhoeae were susceptible to ofloxacin (minimal inhibitory concentration less than or equal to 2 micrograms/ml), whereas roughly 50 percent exhibited intermediate susceptibility to ampicillin (minimal inhibitory concentration, 0.125 to 2.0 micrograms/ml). Post-treatment culture results showed that ofloxacin had eradicated N. gonorrhoeae in 97.5 percent (41 men) of 42 men and all 28 women evaluated. Amoxicillin-probenecid achieved microbiologic cures in 92.7 percent (51 men) of 55 men and 92.6 percent (25 women) of 27 women evaluated. Clinical cure rates among initially symptomatic patients were 84.6 percent (33 men) of 39 men and 81.8 percent (nine women) of 11 women with ofloxacin and 83.0 percent (44 men) of 53 men and 66.7 percent (10 women) of 15 women with amoxicillin-probenecid. No drug-related adverse effects were noted in ofloxacin-treated patients. One patient each in the amoxicillin-probenecid group reported nausea, diarrhea, and vaginitis. These results demonstrate that single-dose ofloxacin is as effective as amoxicillin-probenecid in eradicating N. gonorrhoeae and relieving clinical signs and symptoms of gonococcal infections in both men and women.