Randomized comparative study of 0.5 and 1 g of cefodizime (HR 221) versus 1 g of cefotaxime for acute uncomplicated urogenital gonorrhea.

Uncomplicated urogenital and concomitant oropharyngeal gonorrhea in 424 male and female patients was treated in a randomized comparative study with 0.5 g of cefodizime (89 men and 54 women), 1 g of cefodizime (87 men and 52 women), or 1 g of cefotaxime (86 men and 56 women). The cure rates were 100% for men and women in the group given 0.5 g of cefodizime, 100% for men and women in the group given 1 g of cefodizime, and 99% for men and 100% for women in the group given 1 g of cefotaxime. The MICs of cefodizime and cefotaxime for the isolate of Neisseria gonorrhoeae ranged from 0.004 to 0.06 micrograms/ml. Chlamydia trachomatis was isolated before treatment in 15% and after treatment in 13% of all patients. Side effects, such as nausea, diarrhea, abdominal pain, genital candidiasis, and pain at the site of injection, developed in 4% of the patients given cefodizime. Side effects, such as vertigo, genital candidiasis, fatigability, and diarrhea, developed in 4% of the patients treated with cefotaxime. In both groups of patients, the side effects were mild and transient. Cefodizime and cefotaxime are safe and effective agents in the treatment of uncomplicated urogenital gonorrhea.

RCT Entities:   Population Interventions Outcomes