Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study

Abstract

AstraZeneca.

Pharmacodynamic and pharmacokinetic considerations in the treatment of critically Ill patients infected with carbapenem-resistant Enterobacteriaceae

“…117 Ceftazidime-avibactam was also evaluated in a randomized, open-label trial of patients with ceftazidimeresistant Enterobacteriaceae or P. aeruginosa complicated urinary tract infections or intra-abdominal infections compared to best available therapy (which included a carbapenem in 97% of patients). 118 Clinical cure rates were similar with ceftazidime-avibactam (90.9%) and best available therapy (91.2%). 118 Additional data evaluating clinical outcomes of ceftazidime-avibactam as monotherapy and in combination for the treatment of CRE infections is greatly needed to further establish this agent's role in the treatment of CRE infections.…”

What is the role of the new β-lactam/β-lactamase inhibitors ceftolozane/tazobactam and ceftazidime/avibactam?

“…The non-inferiority of CAZ/AVI plus metronidazole versus meropenem was confirmed in a pooled analysis of two identical phase III clinical trials involving 1066 patients affected by cIAIs [29]. Very recently, CAZ/AVI resulted in cure rates similar to those obtained with 'the best available therapy', in 333 patients suffering from cIAIs or cUTIs by ceftazidime-resistant Enterobacteriaceae and Pseudomonas, in a pathogen-directed trial [30].…”

Ceftazidime/Avibactam: Who Says You Can’t Teach an Old Drug New Tricks?

“…A total of 31.1% of ceftazidime/avibactam and 39.3% best available therapy patients experienced AEs with the most commonly reported being gastrointestinal related (44). Serious adverse events were low at 4.7% and 6.5%.…”

“…The REPRISE study was a prospective, open label evaluation to compare ceftazidime/avibactam efficacy to best available therapy for patients with serious infections, specifically cIAIs and cUTIs, with ceftazidime-resistant isolates (44 Ten cUTI patients (4 ceftazidime/avibactam treated and 6 best available therapy) in the study had a concomitant bacteremia. However, specific outcomes were not described for these patients.…”

“…Overall, ceftazidime/avibactam appears relatively safe from the completed Phase II and III trials for adult and pediatric patients (40)(41)(42)(43)(44). However, the majority of additional safety concerns are from the avibactam component given significant historical safety data with ceftazidime alone.…”