227. Impact of Asymptomatic Bacteriuria on Primary Efficacy Analyses in the Evaluation of Novel Antimicrobials for the Treatment of Patients with Urinary Tract Infection

Abstract Background Per FDA Guidance, the primary efficacy endpoint for trials evaluating antimicrobials treatment of uncomplicated urinary tract infection (uUTI) and complicated (cUTI) is a combined clinical/microbiologic outcome response. Overall success requires both resolution UTI symptoms demonstration that causative uropathogen reduced to < 103 CFU/mL at fixed time point after randomization, regardless whether patient symptomatic. In clinical practice, it not standard care routinely screen or treat asymptomatic bacteriuria (ASB), nor obtain ‘proof cure’ cultures. trial setting, impact post-treatment bladder recolonization on rates microbiologic response, re-infection, emergence resistance unknown. Methods Study IT001-301 -302 are double blind, double-dummy, Phase 3 randomized comparing sulopenem comparator patients with pyuria, bacteriuria, signs/symptoms uUTI cUTI, respectively. 301, 1671 ambulatory female adults were oral bid x 5d ciprofloxacin 3d. 302, 1395 hospitalized cUTI IV once daily followed by ertapenem either amoxicillin-clavulanate bid, depending baseline susceptibility. The was overall (clinical + microbiologic) response in micro-MITT population TOC visit (D12 study D21 study). Results Figure 1 Conclusion Different classes antibiotics appear have differential effect frequency ASB quinolones having lower rate relative beta-lactams. presence week more completing therapy associated higher relapse patients; selection resistant pathogens flora. Inclusion studies should be reconsidered as implies culture obtained document infection, practice inconsistent available recommendations. Disclosures Steven I. Aronin, MD, Iterum Therapeutics: Stocks/Bonds Michael Dunne, Advisor/Consultant|Iterum Board Member|Iterum Sailaja Puttagunta, Stocks/Bonds.