Modern Clinician-initiated Clinical Trials to Determine Optimal Therapy for Multidrug-resistant Gram-negative Infections. (18th November 2019)

• Record Type: Journal Article
• Authors: Stewart, Adam G; Harris, Patrick N A; Chatfield, Mark; Evans, Scott R; van Duin, David; Paterson, David L
• Is Part Of: Clinical infectious diseases. Volume 71:Number 2(2020)
• Page Start: 433
• Page End: 439
• Publication Date: 2019-11-18
• Subjects: gram-negative resistance -- clinical trials -- trial design -- therapeutics; MDR; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciz1132
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: Treatment options for multidrug-resistant (MDR) gram-negative infection are growing. However, postregistration, 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 MDR gram-negative infection trial design is crucial. Abstract : A rising level of gram-negative resistance has sparked recent interest in novel antibiotic development. Limitations in trial design and translation of trial results into the real-world setting has hindered our response. New, clinician-led approaches are needed to overcome these issues.