Adapted from Joshi M, et al. Respir Med. 2006.

*A randomised, double-blind, multicentre study that compared the efficacy and safety of piperacillin/tazobactam and imipenem/cilastatin, both in combination with an aminoglycoside for the treatment of HAP. Patients with HAP received infusions of 4 g/500 mg piperacillin/tazobactam or 500 mg/500 mg imipenem/cilastatin every 6 hours. 

Primary endpoints: clinical cure and microbiological response rates; pathogen eradication rates; length of hospital stay; hospital readmissions; and adverse events (AEs).

Adapted from Naber KG, et al. Int J Antimicrob Agents. 2002.

*A randomised, double-blind, multicentre trial that compared 2 g/0.5 g piperacillin/tazobactam and 0.5 g/0.5 g imipenem/cilastatin every 8 hours, as monotherapy in patients with acute pyelonephritis or complicated urinary tract infections. In total, 237 patients were randomised to receive either piperacillin/tazobactam (n=161) or imipenem/cilastatin (n=166).

Primary endpoints: the bacteriological success rate and the clinical success rate at early follow-up.

Adapted from Graham DR, et al. Clin Inf. 2002.

p=not significant

*A prospective, randomised, double-blind trial comparing 3.375 g piperacillin/tazobactam every 6 hours, with 1 g ertapenem per day as parenteral treatment for 540 adults with cSSSls. The difference in response rates between the groups was -2.0% (95% CI, -10.2% to 6.2%). This indicated that the response rates for the 2 groups were equivalent.

Primary endpoints: the proportion of patients with an investigator assessment of “cure” at the test-of-cure assessment.

Adapted from Yamamoto Y, et al. J Infect Chemother. 2013.

p=0.5909 (non-significant)

*A multicentre, randomised, exploratory study to compare the efficacy and safety of initial empiric therapy with 4.5 g piperacillin/tazobactam every 8 hours (n=18) or 0.5 g meropenem every 8 hours (n=16), in patients with HAP in Japan. Duration of the treatment period was 3 to 14 days in principle, but could be extended to a maximum of 21 days.

Primary endpoints: clinical cure rate at the test-of-cure visit. Clinical cure was evaluated as a cure that indicated continued improvement or complete resolution of symptoms and did not require additional antimicrobial agents 7 days after the end of treatment.

Success without modification

Adapted from Uygun V, et al. Pediatr Blood Cancer. 2009.

*A prospective, randomised, and open-label clinical trial that examines the efficiency and safety of piperacillin/tazobactam monotherapy in comparison to cefepime, for the empirical treatment of paediatric cancer patients with neutropenia and fever. The study evaluated 131 consecutive febrile episodes in neutropenic paediatric cancer patients (n=70). Patients received randomised treatment with either 80 mg/kg piperacillin/10 mg/kg tazobactam every 6 hours, or 50 mg/kg cefepime every 8 hours. Clinical response was determined at completion of therapy.

Treatment outcome criteria: ‘success without modification’ referred to episodes where the patient recovered from fever with disappearance of signs of infection without modifications to initial empirical treatment; ‘overall success’ referred to episodes where the patients recovered from fever with disappearance of signs of infection without failure; ‘failure’ referred to death resulting from a documented or presumed infection during the neutropenic episode.

Adapted from Gorschlüter M, et al. Support Care Cancer. 2003.

*A randomised, open-label study conducted in the Leukemia Unit of the Medical Center of the University of Bonn between July 1996 and May 1999. The study evaluated 212 consecutive febrile episodes in neutropenic patients with haematological malignancies (n=130). Patients were randomised to receive either 4.5 g piperacillin/tazobactam every 8 hours or 2 g ceftriaxone plus gentamicin 5 mg/kg per day, as empiric therapy 

Primary endpoint: response after 72 h of antibiotic therapy.

^†Defervescence = persistent (7 days or more) temperature below 38ºC without antipyretic medication in the absence of clinical signs of continuing infection.
^‡Gentamicin 5mg/kg once daily.