[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].
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) + amikacin (7.5 mg.kg-1 x 2/day) (= cefta-ami) in patients under mechanical ventilation suffering from a nosocomial pneumonia.


METHODS
Multi-centre, open, comparative, randomised study.


METHODS
The study included 275 ICU patients enrolled either in the cefe-ami group (n = 141) or in the cefta-ami group (n = 134).


METHODS
All cases were reviewed in a blinded fashion by the steering committee.


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 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.


CONCLUSIONS
The 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.
Beaucaire
G
G
Service de réanimation et maladies infectieuses, hôpital Dron, Tourcoing, France.
Nicolas
M H
MH
Martin
C
C
Offenstadt
G
G
Philippon
A
A
Holzapfel
L
L
Péan
Y
Y
Léophonte
P
P
Le Fur
D
D
Renard
S
S
D000583:Amikacin / Q000627:therapeutic use*; D000077723:Cefepime; D002442:Ceftazidime / Q000627:therapeutic use*; D002511:Cephalosporins / Q000627:therapeutic use*; D003428:Cross Infection / Q000188:drug therapy* / Q000401:mortality / Q000635:transmission*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005602:France; D006090:Gram-Negative Bacteria / Q000302:isolation & purification; D006094:Gram-Positive Bacteria / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000401:mortality / Q000635:transmission*; D012121:Respiration, Artificial / Q000009:adverse effects*; D015996:Survival Rate
D002511:Cephalosporins; D000077723:Cefepime; D000583:Amikacin; D002442:Ceftazidime