Randomized comparative trial of cefpirome versus ceftazidime in the empirical treatment of suspected bacteraemia or sepsis. Multicentre Study Group.

Cefpirome is a fourth-generation cephalosporin with good in-vitro activity against both Gram-positive and Gram-negative aerobes, including Pseudomonas spp. A multicentre, randomized trial was performed to compare cefpirome at a dose of 2 g bd iv with ceftazidime (2 g tds iv) in the empirical treatment of suspected bacteraemia in patients with severe sepsis but not septic shock. The majority of the patients had community-acquired infections. Patients were stratified into high- and low-risk groups using a Simplified Sepsis Score. Metronidazole, an aminoglycoside or a glycopeptide could be added to the treatment as required. In patients with a positive blood culture treated for > or = 48 h, the clinical success rates were 37/48 (77%) for cefpirome and 35/52 (67%) for ceftazidime with no significant difference between the two. In patients with bacteriologically proven infection, 92 (89%) 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 ceftazidime than to cefpirome (15/90 (17%) and 5/92 (5%) respectively; chi2 = 4.8, P < 0.05) but the bacteriological response was not significantly different between the two groups (cefpirome, 54/60 (90%); ceftazidime, 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 differences between the two treatments, with adverse events thought to be possibly related to the study drug occurring in 55/187 and 40/184 patients on cefpirome and ceftazidime, respectively.