The RESTORE-1 trial, results and real world repercussions – an interview with Keith Kaye

In this extract from an interview originally published on Infectious Diseases Hub, editor Martha Powell interviews Keith Kaye (University of Michigan, MI, USA).

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The RESTORE-1 study recently assessed Merck’s (NJ, USA) investigational beta-lactamase inhibitor, relebactam, in combination with imipenem and results were presented at ID Week (3–7 October 2018, CA, USA).

In light of this, we spoke to Principle Investigator Keith Kaye, from the University of Michigan (MI, USA) about the trial, its results and the importance of assessing new drugs in a real world setting.

First could you just introduce yourself and your background?

I’m an Infectious Diseases Physician at the University of Michigan where I’m the Director of Research for the Infectious Diseases Division. My background has been historically in infection control and antibiotic stewardship and my research is focused mostly on antimicrobial-resistant bacteria, specifically multi-drug and extremely-drug resistant Gram-negatives. I’ve also done a lot of work with healthcare-associated infections and am interested in old antibiotics for new indications, such as colistin, and new antibiotics for new indications.

Could you just introduce the RESTORE-1 study and tell us a bit about the rationale behind it?

The RESTORE-1 trial assessed a novel antibiotic; it coupled a carbapenem (imipenem), which is an old, relied-upon antibiotic, with a novel beta-lactamase inhibitor (relebactam), which is a particularly effective at inhibiting carbapenemase production, particularly Klebsiella pneumoniae carbapenemases (KPCs). Relebactam also inhibits a broad category of other types of beta-lactamases, including extended spectrum beta-lactamases (ESBLs) and it really enhances imipenem’s activity, which is a benefit particularly against these extremely-drug resistant pathogens.

“As a clinician these are the kind of studies we get particularly excited about because they give us a true indication of how IMI/REL will perform in real world settings…”

RESTORE-1 was significant because it mimicked a ‘real world’ use of imipenem–relebactam (IMI/REL). A typical US FDA or EU Phase III study will often study an indication like urinary tract infections (UTIs), for example, where many of the patients who are enrolled don’t actually have the very resistant type pathogens. So while those studies provide very good safety data and some overall efficacy they don’t really give us real world data for how IMI/REL would perform against standard-of-care treatment for highly resistant Gram-negative infections such as carbapenem resistant enterobacteriaceae (CREs) or resistant pseudomonas.

The RESTORE-1 study really focused specifically on patients that had, or were at high-risk for, the extremely-drug resistant infections. As a clinician these are the kind of studies we get particularly excited about because they give us a true indication of how IMI/REL will perform in real world settings and in the types of patients where we might want to use this drug, and really need this drug.

Read the full interview on Infectious Diseases Hub >>


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