RANDOMIZED COMPARATIVE TRIAL OF CEFPIROME VERSUS CEFTAZIDIME IN THE EMPIRICAL-TREATMENT OF SUSPECTED BACTEREMIA OR SEPSIS

Cefpirome is a fourth-generation cephalosporin with good in-vitro acti vity against both Grampositive and Gram-negative aerobes, including Ps eudomonas spp. A multicentre, randomized trial was performed to compar e cefpirome at a dose of 2 g bd iv with ceftazidime (2 g tds iv) in th e empirical treatment of suspected bacteraemia in patients with severe sepsis but not septic shock. The majority of the patients had communi ty-acquired infections. Patients were stratified into high- and low-ri sk groups using a Simplified Sepsis Score. Metronidazole, an aminoglyc oside or a glycopeptide could be added to the treatment as required. I n patients with a positive blood culture treated for greater than or e qual to 48 h, the clinical success rates were 37/48 (77%) for cefpirom e and 35/52 (67%) for ceftazidime with no significant difference betwe en the two. In patients with bacteriologically proven infection, 92 (8 9%) of 103 patients treated with cefpirome were assessed as cured and 94 (89%) of 106 patients with treated ceftazidime. More Gram-positive pathogens, enterococci and staphylococci were resistant in vitro to ce ftazidime than to cefpirome (15/90 (17%) and 5/92 (5%) respectively; c hi(2) = 4.8, P < 0.05) but the bacteriological response was not signif icantly different between the two groups (cefpirome, 54/60 (90%); ceft azidime, 54/63 (86%)). Cefpirome showed equivalent efficacy and safety to ceftazidime in the empirical treatment of suspected bacteraemia or sepsis. Regarding safety, there were no statistically significant dif ferences between the two treatments, with adverse events thought to be possibly related to the study drug occurring in 55/187 and 40/184 pat ients on cefpirome and ceftazidime, respectively.