Piperacillin/tazobactam vs imipenem/cilastatin in the treatment of nosocomial pneumonia--a double blind prospective multicentre study.
BACKGROUND
Piperacillin/tazobactam (P/T) with its broad spectrum of antibacterial activity is used widely for the treatment of moderate to severe polymicrobial nosocomial infections.


METHODS
The efficacy and safety of P/T was compared with imipenem/cilastatin (I/C) in patients with established nosocomial pneumonia. This multicentre study took place from January 1999 to December 2001. Due to difficulties in recruiting sufficient patients it was terminated prematurely. In all, 221 patients were randomly assigned to either P/T at 4 g/0.5 g (n = 110) or I/C at 1 g/1 g (n = 111). Additional aminoglycoside therapy was mandatory if Pseudomonas aeruginosa was present. The ITT population (107 P/T and 110 I/C patients) was used for the analysis of efficacy.


RESULTS
The clinical efficacy was equally good for the P/T and I/C groups; 71% [95% CI 61.3, 79.2] vs 77.3% [95% CI 68.1, 84.5] at the end of therapy, 66.4% [95% CI 56.5, 75] vs 70% [95% CI 60.4, 78.2] on day 3, a nd 59.8% [95% CI 49.9, 69] vs 66.4% [95% CI 56.6, 74.9] on day 14 after therapy, respectively. Proven or assumed bacterial eradication at the end of therapy was 45.8% (P/T) and 52.7% (I/C). Treatment-related adverse events (AE) were recorded in 30% of P/T patients and 25.2% I/C patients. There were ten serious treatment-related AEs in the P/T group and five in the I/C group.


CONCLUSIONS
Although numbers were inadequate for full statistical evaluation, P/T and I/C were similarly effective in the treatment of severe nosocomially acquired pneumonia.
Schmitt
D V
DV
Universitätsklinikum, Herzzentrum Leipzig, Herzchirurgie, Russenstrasse 19, 04289 Leipzig, Germany. schd@medizin.uni-leipzig.de
Leitner
E
E
Welte
T
T
Lode
H
H
D000328:Adult; D015377:Cilastatin / Q000009:adverse effects / Q000627:therapeutic use; D003428:Cross Infection / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D015378:Imipenem / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D010397:Penicillanic Acid / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D010878:Piperacillin / Q000009:adverse effects / Q000627:therapeutic use; D011014:Pneumonia / Q000188:drug therapy*; D011446:Prospective Studies; D011552:Pseudomonas Infections / Q000188:drug therapy; D000078142:Tazobactam; D016896:Treatment Outcome
D015377:Cilastatin; D015378:Imipenem; D010397:Penicillanic Acid; D000078142:Tazobactam; D010878:Piperacillin