This evidence summary – antimicrobial prescribing discusses 3 published randomised controlled trials (RCTs) (REPRISE [Carmeli et al. 2016], RECLAIM 1 and 2 [Mazuski et al. 2016] and RECAPTURE 1 and 2 [Wagenlehner et al. 2016]). RECLAIM 1 and 2 included adults with complicated intra‑abdominal infections and RECAPTURE 1 and 2 included adults with complicated urinary tract infections. Both studies included 2 RCTs that were reported as pooled results and the populations had ceftazidime‑resistant and ‑susceptible pathogens. REPRISE was an open‑label RCT that examined the efficacy of ceftazidime/avibactam in adults with complicated intra‑abdominal infections and in adults with complicated urinary tract infections with only ceftazidime‑resistant pathogens. The majority of the population (92%) in REPRISE had complicated urinary tract infection. There were no published studies to assess the efficacy and safety of ceftazidime/avibactam in adults with hospital‑acquired pneumonia and gram‑negative infections with limited treatment options.
Ceftazidime/avibactam was found to be non-inferior in terms of primary outcomes (see the 2-page summary) to meropenem and doripenem (not available in the UK) for the treatment of complicated intra‑abdominal infections and complicated urinary tract infections respectively in adults with ceftazidime‑resistant and ‑susceptible pathogens (RECLAIM 1 and 2 and RECAPTURE 1 and 2). Similar clinical cure rates were found between ceftazidime/avibactam and best available treatment (mainly with imipenem and meropenem) in REPRISE and there was no statistical comparison conducted between the 2 groups.
The safety profile of ceftazidime/avibactam has generally reflected that already known for ceftazidime alone. However, it is not possible to draw any definitive conclusions regarding the possible effects of avibactam on the adverse event profile of ceftazidime (European Public Assessment Report [EPAR]: ceftazidime/avibactam).
See the 2-page summary for further information on efficacy, safety and resistance.