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Ann Fr Anesth Reanim · Feb 1999
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Phare study. Comparative study of combined cefepime-amikacin versus ceftazidime combined with amikacin in the treatment of nosocomial pneumonias in ventilated patients. Multicenter group study].
- G Beaucaire, M H Nicolas, C Martin, G Offenstadt, A Philippon, L Holzapfel, Y Péan, P Léophonte, D Le Fur, and S Renard.
- Service de réanimation et maladies infectieuses, hôpital Dron, Tourcoing, France.
- Ann Fr Anesth Reanim. 1999 Feb 1; 18 (2): 186-95.
ObjectiveTo 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) + amikacin (7.5 mg.kg-1 x 2/day) (= cefta-ami) in patients under mechanical ventilation suffering from a nosocomial pneumonia.Study DesignMulti-centre, open, comparative, randomised study.PatientsThe study included 275 ICU patients enrolled either in the cefe-ami group (n = 141) or in the cefta-ami group (n = 134).MethodsAll cases were reviewed in a blinded fashion by the steering committee.ResultsMicrobiology laboratory tests were positive in 74% of patients of the cefe-ami group and in 63% of the cefta-ami group respectively; 319 presumed causative strains of bacteria were isolated. The mean duration of treatment was 12 days for cefepime, 11 days for ceftazidime and 8 days for amikacin. In intention to treat, the clinical recovery rate was 48.2% in the cefe-ami group and 44.8% in the cefta-ami group respectively. In the population with a documented pneumonia, the clinical recovery was significantly better 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 bacteriologically documented cases the eradication rates were 86.5% and 89.3% respectively.ConclusionThe efficacy rates of cefe-ami and cefta-ami combinations were similar in ICU patients under mechanical ventilation with a nosocomial pneumonia. However the cefe-ami association was significantly more efficient in the population with a bacteriologically documented pneumonia.
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