drugset / Trial / NCT03329092
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
Phase 3
Completed
422 enrolled
Pfizer
Biomedical Advanced Research and Development Authority · collabInnovative Medicines Initiative · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.
Timeline
- Start
- 2018-04-05
- Primary completion
- 2023-02-23
- Completion
- 2023-02-23
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.
- Carmeli Y, Cisneros JM, Paul M, Daikos GL, Wang M, Torre-Cisneros J, Singer G, Titov I, Gumenchuk I, Zhao Y, Jimenez-Rodriguez RM, Liang L, Chen G, Pyptiuk O, Aksoy F, Rogers H, Wible M, Arhin FF, Luckey A, Leaney JL, Pypstra R, Chow JW; COMBACTE-CARE consortium REVISIT study group. Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. Lancet Infect Dis. 2025 Feb;25(2):218-230. doi: 10.1016/S1473-3099(24)00499-7. Epub 2024 Oct 7.
- 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aztreonam | Small molecule | 2025 mg | Intravenous |
| Subject | Aztreonam | Small molecule | 3000 mg | Intravenous |
| Subject | Aztreonam | Small molecule | 6000 mg | Intravenous |
| Comparator | Meropenem | Small molecule | 500 mg | Intravenous |
| Comparator | Meropenem | Small molecule | 1000 mg | Intravenous |
| Comparator | Meropenem | Small molecule | 2000 mg | Intravenous |
| Subject | avibactam | Small molecule | 675 mg | Intravenous |
| Subject | avibactam | Small molecule | 1000 mg | Intravenous |
| Subject | avibactam | Small molecule | 2000 mg | Intravenous |
| Comparator | Colistin | Other / unclassified | 4e+06 iu | Intravenous |
| Comparator | Colistin | Other / unclassified | 5e+06 iu | Intravenous |
| Comparator | Colistin | Other / unclassified | 6e+06 iu | Intravenous |
| Comparator | Colistin | Other / unclassified | 9e+06 iu | Intravenous |
| Background | Metronidazole | Small molecule | 500 mg | Intravenous |