D V Schmitt1, E Leitner, T Welte, H Lode. 1. Universitätsklinikum, Herzzentrum Leipzig, Herzchirurgie, Russenstrasse 19, 04289 Leipzig, Germany. schd@medizin.uni-leipzig.de
Abstract
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.
RCT Entities:
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.
Authors: Andre C Kalil; Mark L Metersky; Michael Klompas; John Muscedere; Daniel A Sweeney; Lucy B Palmer; Lena M Napolitano; Naomi P O'Grady; John G Bartlett; Jordi Carratalà; Ali A El Solh; Santiago Ewig; Paul D Fey; Thomas M File; Marcos I Restrepo; Jason A Roberts; Grant W Waterer; Peggy Cruse; Shandra L Knight; Jan L Brozek Journal: Clin Infect Dis Date: 2016-07-14 Impact factor: 9.079