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.

PATIENTS AND 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.

CONCLUSION

Although numbers were inadequate for full statistical evaluation, P/T and I/C were similarly effective in the treatment of severe nosocomially acquired pneumonia.