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[Online ahead of print]

Modern Clinician-Initiated Clinical Trials to Determine Optimal Therapy for Multi-Drug Resistant Gram-negative Infections

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Modern Clinician-Initiated Clinical Trials to Determine Optimal Therapy for Multi-Drug Resistant Gram-negative Infections

Adam G Stewart et al. Clin Infect Dis.

Abstract

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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