We conducted a two-center dose ranging study to evaluate the efficacy, tolerance, and toxicity of cefpimizole, a new cephalosporin, in the treatment of uncomplicated gonorrhea in 96 males. Twelve patients at each center were treated intramuscularly with single doses of 1.0, 0.5, 0.2$, and 0.125 g of cefpimizole. All urethral infections were cured at the highest dose, but lower doses produced progressively decreasing cure rates of 90% (0.5 g), 83% (0.25 g), and 71% (0.125 g). Despite recent declines in the reported incidence of gonorrhea (1), consideration of new therapies for gonococcal infections is important from the standpoint of individual practitioners and public health officials. The primary impetus for investigation of new approaches to treatment has been the worldwide emergence of resistance to the antimicrobial agents commonly used for gonorrhea, including spectinomycin (4, 13). Additional problems in gonorrhea therapy include the variable efficacy of antibiotics at sites that are difficult to treat (e.g., the rectum and pharynx); coexisting chlamydial infection; and the need for improvement of antigonococcal treatment regimens in terms of tolerance, toxicity, and cost (13).A number of recently developed 3-lactam antibiotics have been evaluated as single-dose therapy of uncomplicated gonorrhea (5-9, 11, 14, 15, 18, 23). Cefpimizole (U-63196E) is another new broad-spectrum cephalosporin which demonstrates good in vitro activity against Neisseria gonorrhoeae (20). In this study we present data on a two-center, cooperative, dose ranging study of cefpimizole for the treatment of uncomplicated gonorrhea in men. Laboratory methods. Urethral specimens were obtained from all subjects by inserting a calcium alginate swab (Calgiswab; Inolex) 2 to 4 cm beyond the meatus. If indicated by the sexual history, pharyngeal and rectal specimens were collected with cotton-tipped swabs. Specimens were immediately inoculated onto modified Thayer-Martin medium and incubated at 36°C in candle extinction jars or an incubator with an atmosphere of 5% CO2. N. gonorrhoeae was identified by standard techniques of colony morphology, Gram stain, and oxidase reactions (19). Isolated colonies were subcultured onto chocolate agar medium before they were stored at -70°C in 50% horse serum diluted in Trypticase soy broth (BBL Microbiology Systems, Cockeysville, Md.). MICs of cefpimizole, penicillin G, spectinomycin, tetracycline, and cefotaxime were determined by the agar dilution technique with a gonococcal agar base containing 1% hemoglobin and 1% IsoVitaleX (BBL). Production of P-lactamase was tested by the chromogenic cephalosporin technique in
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