TREATMENT OF SERIOUS INFECTIONS WITH CEFOTAXIME UTILIZING AN OUTPATIENT DRUG-DELIVERY DEVICE - GLOBAL ANALYSIS OF A LARGE-SCALE, MULTICENTER TRIAL

The primary objective of this multicenter, prospective trial was to de termine the safety, efficacy, and cost effectiveness of cefotaxime del ivered via an ambulatory delivery system (ADS) in the treatment of pat ients with a variety of bacterial infections. The secondary objective was to determine the safety and efficacy of cefotaxime/ADS treatment o f infections in a diabetic subgroup. A total of 238 patients (greater than or equal to 18 years) in five infection categories were enrolled from 10 sites. All patients received cefotaxime/ADS. Both global analy sis and analysis of a subpopulation with diabetes mellitus were perfor med. Of the 211 patients who completed the study, 201 patients (95.3%) exhibited a satisfactory or improved clinical response following cefo taxime/ADS. Bacteriologic response, evaluable in 134 of 211 patients, was satisfactory in 125 of these patients (93.3%). Within the diabetes mellitus subpopulation, a satisfactory or improved clinical response was identified in 30 of 32 patients (93.8%). In conclusion, administra tion of cefotaxime via ADS is a well-tolerated, safe, and clinically e ffective treatment of serious infection and may be less expensive than inpatient intravenous antibiotic therapy.