cUTI Trial 1—RECAPTURE
cUTI Phase 3 clinical trial vs doripenem
Type of Trial
Phase 3, multinational, multicenter, double-blind, randomized, noninferiority trial
1020 adults hospitalized with cUTI, which included acute pyelonephritis and complicated lower urinary tract infections.
The microbiologically modified intent-to-treat (mMITT) population, which included all patients who had at least one uropathogen isolated at baseline (≥105 CFU/mL), consisted of 810 patients; the median age was 55 years, and 69.8% were female.
AVYCAZ® 2.5 g (ceftazidime 2 grams and avibactam 0.5 grams) IV every 8 hours
Doripenem 0.5 grams IV every 8 hours
A switch to an oral antimicrobial agent was allowed after 5 days of IV dosing.
10 to 14 days
Symptom response rates at Day 5 and combined microbiological cure and symptom response rates at the TOC visit (21 to 25 days after randomization). A symptom response was based on the resolution of patient-reported cUTI symptoms, defined as frequency/urgency/dysuria/suprapubic pain, as well as an improvement in flank pain for individuals with acute pyelonephritis. Microbiological cure was defined as a reduction of all baseline uropathogens to less than 104 CFU/mL in the urine.
CFU, colony-forming unit.
Clinical efficacy in cUTI demonstrated in a Phase 3 trial vs doripenem1
- AVYCAZ was noninferior to doripenem with regard to both primary endpoints1
CLINICAL AND MICROBIOLOGICAL CURE RATES (mMITT)1
mMITT, microbiologically modified intent-to-treat.
CI, confidence interval.
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
CEFTAZIDIME-NS SUBSET POPULATION: MICROBIOLOGICAL AND CLINICAL CURE RATES AT TOC (mMITT)1
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:
ESBLs, extended-spectrum beta-lactamases.
Clinical data by pathogen
MICROBIOLOGICAL CURE RATE BY BASELINE PATHOGEN AT TOC (mMITT)1
TOC, test of cure.