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OASIS

Outcomes among patients treated with Imipenem-Relebactam versus comparator regimens for Difficult-to-Treat Gram-Negative Infections


Background

There are a limited number of antibacterial agents active against multidrug-resistant (MDR) and extensively drug-resistant Gram-negative priority pathogens, as defined by The World Health Organization.1 Imipenem-relebactam is a novel carbapenem-β-lactamase inhibitor combination recommended as a front-line treatment option for MDR Pseudomonas aeruginosa and carbapenem-resistant Enterobacterales (CRE). The available clinical evidence for imipenem-relebactam is limited to two phase-III randomized clinical trials that enrolled few patients infected with these pathogens.2,3 Real-world evidence is emerging, but limited by significant heterogeneity, residual confounding, and the lack of a comparison between the effectiveness of imipenem-relebactam versus comparator agents.

Details

OASIS is a multinational, multicenter, retrospective, observational study designed to describe the real-world effectiveness of imipenem-relebactam, and to compare its effectiveness to alternative treatment options globally. Bloodstream infections or pneumonia due to MDR P. aeruginosa and Klebsiella pneumoniae carbapenemase (KPC)-producing CRE will be included. Patients will be matched 1:1 within each site based on pathogen, resistance mechanism, infection site (pneumonia or bacteremia), severity of illness, and time to treatment initiation.  

Progress

Preliminary regulatory and contracting work is underway. Data collection is expected to begin in early 2026.

References

1. WHO Bacterial Priority Pathogens List. World Health Organization; 2024.
2. Motsch J, et al. Clin Infect Dis. 10.1093/cid/ciz530
3. Titov I, et al. Clin Infect Dis. 10.1093/cid/ciaa803