Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria

Summary

Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) and ventilator associated pneumonia (VAP), complicated urinary tract infections (cUTI), or bloodstream infections (BSI) due to metallo-β-lactamase (MBL)- producing Gram-negative bacteria.

Timeline

Start

2020-12-25

Primary completion

2023-01-23

Completion

2023-01-23

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment of patients with serious infections caused by gram-negative bacteria producing MBL has been challenging. Date study terminated: 16-Dec-2022.”

Publications

• Raber SR, Xie R, Rogers H, Soto E, Arhin FF, Stone GG, Leister-Tebbe H, Chow JW. Microbiological, Clinical, and Pharmacokinetic/Pharmacodynamic Data to Support EUCAST Aztreonam-Avibactam Minimum Inhibitory Concentration Susceptibility Breakpoints Against Enterobacterales. Infect Dis Ther. 2026 Jan;15(1):183-195. doi: 10.1007/s40121-025-01267-3. Epub 2025 Nov 21.
• Xie R, Rogers H, Chow JW, Soto E, Raber SR. Population pharmacokinetic/pharmacodynamic modeling to optimize aztreonam-avibactam dose regimens for adult patients. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0195024. doi: 10.1128/aac.01950-24. Epub 2025 Jun 18.
• Das S, Riccobene T, Carrothers TJ, Wright JG, MacPherson M, Cristinacce A, McFadyen L, Xie R, Luckey A, Raber S. Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation. Eur J Clin Pharmacol. 2024 Apr;80(4):529-543. doi: 10.1007/s00228-023-03609-x. Epub 2024 Jan 22.

Drugs

Indications