A MULTICENTER, RANDOMIZED COMPARATIVE-STUDY OF 500 MG VERSUS 1,000 MGCEFTAZIDIME TDS FOR TREATMENT OF GRAM-NEGATIVE INFECTIONS

A multicentre, randomized study was performed to compare the clinical and bacteriological efficacy of 500 mg ceftazidime i,v, t.d,s, with 1, 000 mg ceftazidime i,v, t,d,s, for treatment of hospitalised, non-comp romised patients with gram-negative infections, The study was conducte d in ten hospitals in The Netherlands, Hospitalised patients with a su spected gram-negative lower respiratory tract infection, complicated u rinary tract infection or septicaemia were included, Excluded were pat ients with neutropenia, limited life expectancy, or severe renal insuf ficiency as well as those on antibiotics in the 48 h prior to entry, C eftazidime was administered via an intravenous infusion every 8 h, For patients with moderately impaired renal function the frequency was re duced to 12 h, Treatment was continued for as long as clinically indic ated, Clinical response (cure, improvement or failure) and bacteriolog ical response (elimination, persistence or non-evaluable) were assesse d primarily by the investigator, Final assessments were made by a pane l of experts without prior knowledge. In total 127 patients were rando mized, 64 patients to the 500 mg group and 63 to the 1,000 mg group; 4 7 patients were excluded from evaluation, usually due to an incorrect diagnosis prior to randomization, Ultimately 37 patients of the 500 mg group and 43 patients of the 1,000 mg group were available for evalua tion, Between these two groups of evaluable patients there were no sig nificant differences in baseline characteristics, types of infection, isolated bacterial pathogens or treatment characteristics. There was n o significant difference in either clinical or bacteriological efficac y, Therefore 500 mg ceftazidime i,v, t,d,s, can be considered optimal therapy for gram-negative lower respiratory tract infections, complica ted urinary tract infections and septicaemia in hospitalised, non-comp romised patients.