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 determine the safety, efficacy, and cost effectiveness of cefotaxime delivered via an ambulatory delivery system (ADS) in the treatment of patients with a variety of bacterial infections. The secondary objective was to determine the safety and efficacy of cefotaxime/ADS treatment of infections in a diabetic subgroup. A total of 238 patients (≥18years) in five infection categories were enrolled from 10 sites. All patients received cefotaxime/ADS. Both global analysis and analysis of a subpopulation with diabetes mellitus were performed. One of the 211 patients who completed the study, 201 patients (95.3%) exhibited a satisfactory or improved clinical response following cefotaxime/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, administration of cefotaxime via ADS is a well-tolerated, safe, and clinically effective treatment of serious infection and may be less expensive than inpatient intravenous antibiotic therapy.