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cUTI Phase 3 clinical trial vs doripenem

chart showing RECAPTURE Study design

CFU, colony-forming unit.

IV, intravenous.

TOC, test of cure.

Clinical efficacy in cUTI demonstrated in a Phase 3 trial vs doripenem1

  • AVYCAZ was noninferior to doripenem with regard to both primary endpoints1
A chart of clinical cure rates at TOC (mMITT and ME), including cases with ESBLs and AmpC
  • Microbiological cure at TOC was 77.4% (304/393) for AVYCAZ and 71.0% (296/417) for doripenem, a treatment difference of 6.4 (95% CI: 0.3, 12.4)1
  • Symptomatic response at TOC was 84.5% (332/393) for AVYCAZ and 86.3% (360/417) for doripenem, a treatment difference of -1.9 (95% CI: -6.8, 3.0)1

Subset populations

Clinical efficacy in cUTI caused by ceftazidime-NS Gram-negative pathogens1

  • At baseline, 75 patients in the AVYCAZ arm and 84 patients in the doripenem arm of the mMITT population had Gram-negative isolates that were not susceptible to ceftazidime1
Chart showing RECAPTURE microbiological and clinical cure rates at TOC

ESBLs, extended-spectrum β-lactamases.

NS, nonsusceptible.

TOC, test of cure.

Clinical efficacy in cUTI involving ESBLs and AmpC1

  • In a subset of Gram-negative pathogens from the Phase 3 cUTI trial, genotypic testing identified certain ESBL groups and AmpC in 21.7% (176/810) of patients in the mMITT population, all of which were expected to be inhibited by avibactam1:
Clinical cure rates in subset for AVYCAZ plus metronidazole were similar to the overall results

Clinical data by pathogen

Table showing RECAPTURE Microbiological cure rates by pathogen at TOC