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cIAI Trial—RECLAIM

cIAI Phase 3 clinical trial vs meropenem

chart depicting Phase 3 study design

IV, intravenous.

Clinical efficacy in cIAI demonstrated in a Phase 3 trial vs meropenem1

  • AVYCAZ plus metronidazole was noninferior to meropenem with regard to the clinical cure rate at the TOC visit in the mMITT population1
chart depicting clinical cure rates at TOC

*The microbiologically evaluable (ME) population included all protocol-adherent mMITT patients.1

CI, confidence interval.

mMITT, microbiologically modified intent-to-treat.

TOC, test of cure.

Subset populations

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

  • At baseline, 111 patients in the mMITT population had Gram-negative isolates that were not susceptible to ceftazidime, including 61 patients with E. coli and 26 patients with K. pneumoniae1
chart showing Clinical cure rates at TOC overall analysis subset populations

mMITT, microbiologically modified intent-to-treat.

NS, nonsusceptible.

TOC, test of cure.

Clinical efficacy in cIAI involving ESBLs and AmpC1

  • In a subset of Gram-negative pathogens from the Phase 3 cIAI trial, genotypic testing identified certain ESBL groups and AmpC in 12.8% (105/823) of patients in the mMITT population, all of which were expected to be inhibited by avibactam1:
Graphic showing clinical efficacy in a subset of cIAI patients

ESBLs, extended-spectrum β-lactamases.

Clinical data by pathogen

Graphic showing clinical cure rates by baseline pathogen

TOC, test of cure.