Levofloxacin in the empirical treatment of patients with suspected bacteraemia/sepsis: comparison with imipenem/cilastatin in an open, randomized trial

An open, randomized, multinational, multicentre study was conducted to comp are the efficacy, safety and tolerability of levofloxacin 500 mg twice dail y with imipenem/cilastatin 1 g iv three-times daily in the treatment of hos pitalized adult patients with clinically suspected bacteraemia/ sepsis. Lev ofloxacin patients could change from iv to oral administration after a mini mum of 48 h iv treatment if clinical signs and symptoms of sepsis had impro ved. The primary efficacy analysis was based on the clinical and bacteriolo gical response at clinical endpoint. A total of 503 patients were randomize d and 499 included in the intent-to-treat population. The perprotocol popul ation comprised 287 patients with bacteriologically proven infection. Clini cal cure rates at clinical endpoint in the intent-to-treat population and p er-protocol population were 77% (184/239) and 89% (125/140), respectively, for levofloxacin and 68% (178/260) and 85% (125/147), respectively, for imi penem/cilastatin. At follow-up, the cure rates in the per-protocol populati on were 84% for levofloxacin and 69% for imipenem/cilastatin. The 95% confi dence interval for both populations showed that levofloxacin was as effecti ve as imipenem/cilastatin. A satisfactory bacteriological response was obta ined in 87% (96/110) of levofloxacin patients and 84% (97/116) of imipenem/ cilastatin patients at clinical endpoint. Adverse events possibly related t o the study drug were reported in 74 (31%) levofloxacin patients and 79 (30 %) imipenem/cilastatin patients. There were no clinically appreciable diffe rences between the treatment groups. Levofloxacin 500 mg twice daily, eithe r iv or as sequential iv/oral therapy, was as effective and well tolerated as imipenem/cilastatin 1 g iv three-times daily in the treatment of hospita lized patients with suspected bacteraemia/sepsis.