Treatment options for multidrug resistant (MDR) Gram-negative infection are growing. However, post-registration, pragmatic and clinician-led clinical trials in this field are few, recruit small sample sizes, and experience deficiencies in design and operations. MDR Gram-negative therapeutic trials are often inefficient, only evaluating a single antibiotic or strategy at a time. Novel clinical trial designs offer potential solutions by attempting to obtain clinically meaningful conclusions at the end or during a trial, for many treatment strategies, simultaneously. An integrated, consensus approach to multidrug resistant Gram-negative infection trial design is crucial.
Keywords: Gram negative resistance; clinical trials; therapeutics; trial design.
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