Phare study. Comparative study of the association cefepime-amikacin versusthe association ceftazidime-amikacin in the treatment of nosocomial pneumonias in ventilated patients

Objective: To compare the associations of cefepime (2 g x 2/day) + amikacin (7.5 mg.kg(-1) x 2/day) (= cefe-ami) and ceftazidime (2 g x 3/day) + amika cin (7.5 mg.kg(-1) x 2/day) (= cefta-ami) in patients under mechanical vent ilation suffering from a nosocomial pneumonia. Study design: Multi-centre, open, comparative, randomised study. Patients: The study included 275 ICU patients enrolled either in the cefe-a mi group (n = 141) or in the cefta-ami group (n = 134). Methods: All cases were reviewed in a blinded fashion by the steering commi ttee. Results: Microbiology laboratory tests were positive in 74% of patients of the cefe-ami group and in 63% of the cefta-ami group respectively; 319 pres umed causative strains of bacteria were isolated. The mean duration of trea tment was 12 days for cefepime, 11 days for ceftazidime and 8 days for amik acin. In intention to treat, the clinical recovery rate was 48.2% in the ce fe-ami group and 44.8% in the cefta-ami group respectively. In the papulati on with a documented pneumonia, the clinical recovery was significantly bet ter in the cefe-ami group (53.3%), than in the cefta-ami group (39.3%) (P = 0.05). In per protocol analysis, these rates reached 67.7% in the cefe-ami group and 68.2% in the cefta-ami group respectively. In the bacteriologica lly documented cases the eradication rates were 86.5% and 89.3% respectivel y. Conclusion: The efficacy rates of cefe-ami and cefta-ami combinations were similar in ICU patients under mechanical ventilation with a nosocomial pneu monia. However the cefe-ami association was significantly more efficient in the population with a bacteriologically documented pneumonia. (C) 1999 Els evier, Paris.