Multi-resistant strains of Gram-negative bacteria are rapidly emerging as a frequent cause of serious bacterial infection in the hospital environment. Effective treatment must include an antibiotic with activity against these organisms. In an open multicentre study, cefepime was evaluated as empirical therapy in 156 hospitalized patients (mean age 57 years) with serious infection of the urinary tract (n = 43), lower respiratory tract (n = 101) and skin and soft tissue (n = 12). In 18 patients, septicaemia/bacteraemia was also diagnosed. Cefepime, 2 g bd, was administered for a maximum of 16 days (mean 8). Of 98 pathogens isolated, 75 were Gram-negative and 23 were Gram-positive species. Ninety-four of the pathogens were susceptible to cefepime, including multi-resistant isolates such as Pseudomonas aeruginosa and Enterobacter cloacae. The overall clinical cure rate, excluding septicaemia/bacteraemia, was 92% (94/102); the corresponding bacterial eradication rate was 95% (52/55). In patients with septicaemia/bacteraemia, the clinical cure rate was 87% (13/15) despite eradication of 100% (11/11) of the assessable pathogens. Cefepime was well-tolerated, although 14 (9%) patients experienced local intolerance at the infusion site. Other drug-related adverse events were reported in six (4%) patients and included diarrhoea, pruritus, rash and urticaria. Cefepime is safe and effective as empirical treatment for serious infections commonly found in the hospital setting. Clinical cure and bacterial eradication can be achieved with a convenient bd dosing schedule.