Discordant outcomes at cUTI test-of-cure visit associated with risk of clinical failure

An analysis of phase 3 trials of patients with complicated UTIs found that having discordant outcomes at a test-of-cure visit — clinical success but microbiological failure — was associated with an increased risk for late clinical failure.
“When evaluating clinical trials for antibacterial drugs for complicated urinary tract infections (cUTIs), the FDA currently recommends a composite endpoint [composed of] the clinical and microbiological responses,” Nadia Kadry, PhD, and Mukil Natarajan, MD, both of the FDA’s Center for Drug Evaluation and Research, told Healio.
“In

An analysis of phase 3 trials of patients with complicated UTIs found that having discordant outcomes at a test-of-cure visit — clinical success but microbiological failure — was associated with an increased risk for late clinical failure.
“When evaluating clinical trials for antibacterial drugs for complicated urinary tract infections (cUTIs), the FDA currently recommends a composite endpoint [composed of] the clinical and microbiological responses,” Nadia Kadry, PhD, and Mukil Natarajan, MD, both of the FDA’s Center for Drug Evaluation and Research, told Healio.
“In