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cUTI Trial 2—REPRISE

Chart depicting REPRISE study design

CFU, colony-forming unit.

IV, intravenous.

MIC, minimum inhibitory concentrations.

mMITT, microbiologically modified intent-to-treat.

TOC, test of cure.

In a trial vs carbapenems and colistin...

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

  • AVYCAZ demonstrated a higher cure rate with regard to the combined clinical and microbiological cure vs best available therapy (BAT)* at the Day 21 to 25 visit1
A chart of clinical cure rates in the Overall analysis population and Ceftazidime-NS Gram-negative pathogens

* Best available therapy (BAT) options were meropenem, imipenem, doripenem, and colistin; the majority of patients received carbapenem monotherapy.1

mMITT, microbiologically modified intent-to-treat.

NS, nonsusceptible.

  • Clinical cure at the Day 21 to 25 visit was 88.2% (127/144) for AVYCAZ and 88.3% (121/137) for BAT, a treatment difference of -0.1 (95% CI: -7.9, 7.7)1
  • Microbiological cure at the Day 21 to 25 visit was 71.5% (103/144) for AVYCAZ and 56.9% (78/137) for BAT, a treatment difference of 14.6 (95% CI: 3.4, 25.5)1

Subset population

Clinical efficacy demonstrated in cUTI involving ESBLs and AmpC, including KPC-producing CRE1

  • In a subset of Gram-negative uropathogens, genotypic testing identified certain ESBL groups and AmpC in 97.2% (273/281) of patients in the mMITT population, all of which were expected to be inhibited by avibactam1:
table showing REPRISE data for ESBLs and AmpC

ESBLs, extended-spectrum β-lactamases.

KPC, Klebsiella pneumoniae carbapenemase.

CRE, carbapenem-resistant Enterobacteriaceae.

mMITT, microbiologically modified intent-to-treat.

NS, nonsusceptible.

Clinical efficacy in cUTI across baseline ceftazidime-NS Gram-negative pathogens1

chart showing REPRISE Microbiological response rates by baseline ceftazidime-NS pathogen at day 21-25 visit

mMITT, microbiologically modified intent-to-treat.

NS, nonsusceptible.