Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Summary

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

Timeline

Start

2023-05-23

Primary completion

2024-11-22

Completion

2024-11-26

Publications

• Takahashi S, Tateda K, Yanagihara K, Huang H, Doi Y, Yasuda M, Matsumoto K, Sumiya M, Takaya R, Suwada K, Kamiyabu S, Sasagawa Y, Minamida T, Kato S, Kondo K, Naruse T, Mikamo H. Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial. Lancet. 2026 May 16;407(10542):1929-1940. doi: 10.1016/S0140-6736(26)00596-9.

Drugs

Indications