ArticleInfectious diseases and therapy2026
Microbiological, Clinical, and Pharmacokinetic/Pharmacodynamic Data to Support EUCAST Aztreonam-Avibactam Minimum Inhibitory Concentration Susceptibility Breakpoints Against Enterobacterales.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 3 prospective, randomized, multicenter, open-label, central assessor-blinded, parallel group, comparative study to determine the efficacy, safety and tolerability of aztreonam-avibactam (atm-avi) ±metronidazole (mtz) versus meropenem±colistin (mer±col) for the treatment of serious infections due to gram negative bacteria, including metallo-β-lactamase (mbl) - producing multidrug resistant pathogens, for which there are limited or no treatment options
A prospective, randomized,open-label, comparative study to assess the efficacy, safety and tolerability of aztreonam- avibactam (atm-avi) and best available therapy for the treatment of serious infections due to multi-drug resistant gram- negative bacteria producing metallo -β-lactamase (mbl)
Who cites it
2 citing papers in PubMed.
- Susceptibility to novel antimicrobial agents and molecular epidemiology of carbapenem-resistant enterobacterales: a 9-year study in Central China.BMC microbiology · 2026Article
- Aztreonam-avibactam therapy following surgical source control forFrontiers in pharmacology · 2026Article
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Authors and funding
8 authors.
Funding
Abstract
introductionAztreonam-avibactam was approved for adults with limited treatment options for multiple infections due to aerobic Gram-negative organisms in the European Union and for complicated intra-abdominal infection in the US, following the phase 3 REVISIT and ASSEMBLE trials. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) assigned minimum inhibitory concentration (MIC) breakpoints for aztreonam-avibactam against Enterobacterales of susceptible ≤ 4 mg/l and resistant > 4 mg/l.
methodsA comprehensive synthesis of data supporting MIC breakpoint determination is summarized, including: joint probability of pharmacokinetic/pharmacodynamic target attainment (JPTA) analyses (based on population pharmacokinetic modeling) for aztreonam-avibactam dose selection; MIC distributions of target pathogens; clinical and microbiological efficacy outcomes; and exposure-response analyses.
resultsAmong 100,228 Enterobacterales isolates, including 2449 metallo-β-lactamase-positive isolates from global surveillance studies (2017-2021), 99% had aztreonam-avibactam MICs of ≤ 8 mg/l. At MIC = 8 mg/l, the predicted JPTA at steady state was 89% to > 99% across subgroups of varying renal function, based on approved doses for aztreonam-avibactam. Clinical trial isolates fell within the same MIC distribution as surveillance studies. There was no evidence of decreased favorable microbiological responses with increasing aztreonam-avibactam MICs in clinical trials; however, in the clinical dataset, there were few Enterobacterales isolates with aztreonam-avibactam MICs of > 4 mg/l.
conclusionsMIC distributions and JPTA simulations supported a susceptible MIC breakpoint for aztreonam-avibactam against Enterobacterales of ≤ 8 mg/l. However, limited clinical outcomes data for Enterobacterales with aztreonam-avibactam MIC ≥ 4 mg/l justified the more conservative breakpoints established by EUCAST. CLINICAL
trial registrationClinicalTrials.gov, NCT03329092 and NCT03580044. Studies/analyses sponsored by Pfizer.
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