Methods: cUTI trials for 6 new antibiotics developed to treat multi-drug resistant Gram‑negative infections were obtained from publicly disclosed information including FDA documents, publications, or presentations at scientific meetings. Antibiotics included were: ceftolozane-tazobactam (CTL‑TAZ), ceftazidime-avibactam (CTZ-AVI), meropenem‑vaborbactam (MER-VAB), cefiderocol, plazomicin, and fosfomycin. Comparison variables included: mMITT sample size, age, % female patients, % acute pyelonephritis, % E. coli and other pathogens at baseline, switch to PO antibiotic, and the non-inferiority margin. Other variables as well as the microbiologic eradication, clinical response, and the combined outcomes will be included in the poster.
Non-inferiority margin (%)
Age, years (mean)
Acute pyelonephritis (%)
E. coli (%)
Conclusion: Study design and eligibility criteria significantly influences patient characteristics. The proportion of acute pyelonephritis varied greatly and influenced population demographics (age, gender) and baseline microbiology. Studies with a smaller proportion of acute pyelonephritis resulted in an older patient population, fewer females and less E. coli. Larger sample size did not impact outcomes.
S. Portsmouth, Shionogi Inc: Employee , Salary .
A. Howell, Shionogi Inc.: Employee , Salary .