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Clinical Trial
. 2025 Feb 26;12(4):ofaf112.
doi: 10.1093/ofid/ofaf112. eCollection 2025 Apr.

Real-World Applications of Imipenem-Cilastatin-Relebactam: Insights From a Multicenter Observational Cohort Study

Kaylee E Caniff  1 , Nicholas Rebold  1   2 , Xhilda Xhemali  3 , Nikki Tran  4 , Taryn A Eubank  5 , Kevin W Garey  5 , Yi Guo  6 , Mei Chang  6 , Katie E Barber  7 , Tamara Krekel  8 , Mark Biagi  9 , Wesley D Kufel  10   11 , Amy Carr  12 , Jillian Hayes  12 , Travis J Carlson  13   14 , Jeremy Frens  14 , Veena Venugopalan  15 , Kristen Lucas  16 , Ashlan J Kunz Coyne  16 , James Sanders  17 , Elisabeth Chandler  18 , Rosanna Li  19 , Kayla Antosz  20   21 , Julie Ann Justo  20   21 , Russell Benefield  22 , W Justin Moore  23 , Jennifer Ross  24 , Jenna Adams  25 , Fritzie Albarillo  26 , Sylvia Stefanos  27 , Athena L V Hobbs  27 , Nicholas Mercuro  28 , Brian Raux  29 , Kristen Zeitler  30 , Michael J Rybak  1   31
Affiliations
Clinical Trial

Real-World Applications of Imipenem-Cilastatin-Relebactam: Insights From a Multicenter Observational Cohort Study

Kaylee E Caniff et al. Open Forum Infect Dis. .

Abstract

Background: Multidrug-resistant (MDR) gram-negative infections are a substantial threat to patients and public health. Imipenem-cilastatin-relebactam (IMI/REL) is a β-lactam/β-lactamase inhibitor with expanded activity against MDR Pseudomonas aeruginosa and carbapenem-resistant Enterobacterales. This study aims to describe the patient characteristics, prescribing patterns, and clinical outcomes associated with IMI/REL.

Methods: This was a retrospective, multicenter, observational study of patients ≥18 years old who received IMI/REL for ≥48 hours for a suspected or confirmed gram-negative infection. The primary outcome was clinical success, defined as improvement or resolution of infection-related signs or symptoms while receiving IMI/REL and the absence of 30-day microbiologic failure. Multivariable logistic regression analysis was performed to identify independent predictors of clinical success.

Results: The study included 151 patients from 24 US medical centers. IMI/REL was predominantly prescribed for lower respiratory tract infections, accounting for 52.3% of cases. Most patients were infected with a carbapenem-nonsusceptible pathogen (85.4%); P aeruginosa was frequently targeted (72.2%). Clinical success was achieved in 70.2% of patients. Heart failure, receipt of antibiotics within the past 90 days, intensive care unit admission at time of index culture collection, and isolation of difficult-to-treat resistant P aeruginosa were independently associated with a reduced odds of clinical success. Adverse events were reported in 6.0% of patients, leading to discontinuation of IMI/REL in 3 instances.

Conclusions: This study provides a comprehensive analysis of the real-world effectiveness and safety of IMI/REL. Comparative studies and investigations of specific subgroups will further enhance our understanding of IMI/REL in treating MDR infections.

Keywords: Pseudomonas aeruginosa; carbapenem-resistant; gram-negative; imipenem-cilastatin-relebactam; multidrug-resistant.

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Conflict of interest statement

Potential conflicts of interest. T. K. has served on speaker bureaus and as a consultant for AbbVie and Shionogi. J. A. J. has served on advisory boards for bioMérieux and Shionogi. M. J. R. has received research support from Merck, Innoviva, Paratek Pharmaceuticals, AbbVie, and Melinta; has served on an advisory board for Innoviva; and has served on speaker bureaus for Innoviva and AbbVie. All other authors report no potential conflicts.

Figures

Figure 1.
Figure 1.
Imipenem-cilastatin-relebactam susceptibility testing methods and interpretation for Pseudomonas aeruginosa (n = 67) and Enterobacterales (n = 26) isolates.
See this image and copyright information in PMC

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