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In the micro-MITTR population, sulopenem demonstrated superiority to ciprofloxacin (p < 0.001). In the micro-MITTS population, sulopenem was not non-inferior to ciprofloxacin for the primary endpoint, driven primarily by the higher rate of asymptomatic bacteriuria post treatment in patients on sulopenem. In the combined analysis of all randomized patients with an organism identified at baseline (MITTR+MITTS), sulopenem was non-inferior to ciprofloxacin.
Treatment emergent adverse events occurred more frequently in sulopenem patients (all, 24.8% vs 13.9%; related, 17.0% vs 6.2%), accounted for by a higher incidence of self-limited diarrhea (12.4% vs 2.5%). Serious adverse events were similar on each regimen.
Conclusion: Sulopenem was superior to ciprofloxacin for the treatment of adult women with uUTI due to quinolone non-susceptible pathogens. Sulopenem was not non-inferior in the treatment of quinolone susceptible pathogens, driven by a lower rate of asymptomatic bacteriuria in patients receiving ciprofloxacin, but was non-inferior in the combined population of patients.
Michael W. Dunne, MD
Chief Scientific Officer
Iterum Therapeutics
Old Saybrook, CT
Disclosure: Iterum Therapeutics (Employee, Shareholder)
Anita F. Das, PhD
Project Statistician
AD Stat Consulting
Guerneville, CA
Disclosure: Iterum Therapeutics (Consultant)
Michael Zelasky, BS
Head of Biostatistics, Statistical Programming and Data Management
Iterum Therapeutics
Old Saybrook, Connecticut
Disclosure: Iterum Therapeutics (Employee)
Karthik Akinapelli, BS
Lead Statistician
Iterum Therapeutics
Old Saybrook, Connecticut
Disclosure: Iterum Therapeutics (Employee)
Helen Boucher, MD
Director, Tufts Center for Integrated Management of Antimicrobial Resistance
Tufts Medical Center
Boston, MA
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Steven I. Aronin, MD
Senior Director, Clinical Development
Iterum Therapeutics
Old Saybrook, Connecticut
Disclosure: Iterum Therapeutics (Employee)