IMIPENEM CILASTATIN THERAPY OF SERIOUS INFECTIONS - A UNITED-STATES MULTICENTER NONCOMPARATIVE TRIAL

Imipenem/cilastatin, which combines a broad-spectrum antibiotic derived from thienamycin with a specific enzyme inhibitor, was administered in dosages of 1-4 g/day to 717 patients in a multicenter noncomparative trial. Of the bacterial pathogens, 99% tested were susceptible to imipenem, and 86% were eradicated. Clinical outcome was favorable in .gtoreq. 85% of the cases when assessed according to the site of infection, and 92% of the cases responded to treatment overall. Development of resistance was rare except for Pseudomonas aeruginosa, which became resistant in 19% of the patients infected with that organism. More than half the patients with resistant P. aeruginosa had a favorable clinical outcome, however. Superinfection occurred in .apprx. 4% of all patients. The adverse clinical experiences occurring most frequently were related to gastrointestinal function (nausea, vomiting, and diarrhea). In general, the safety profile of imipenem/cilastatin was similar to that of other .beta.-lactam antibiotics.