Our goal is to create and implement an Antibacterial Resistance Leadership Group (ARLG) that will develop, design, implement, and manage a clinical research agenda that will increase knowledge of and mitigate the important factors that drive resistance. We will pair an unprecedented team of over two dozen of the world's top investigators with the organizational excellence of the Duke Clinical Research Institute (DCRI), one of the world's largest Academic Research Organizations. Because of the complexity of integrating multiple components of such a large-scale clinical research network, our submission features centralized leadership through an Executive Committee and a dual PI approach. One PI (Fowler) focuses primarily on operations and the other (Chambers) focuses largely on scientific agenda. The organizational structure, modeled after that of the ACTG, also features Scientific Subcommittees devoted to four priority areas: Gram-negative bacterial infections, Stewardship and infection prevention, Gram-positive bacterial infections, and Diagnostics and devices. These Subcommittees are supported by three Special Emphasis Panels (SEPs) (Pediatrics, Pharmacokinetics, and Special Populations) and a Mentoring Core. Each Subcommittee, SEP, and Core contains internationally recognized investigators, ensuring expertise. To complement the current research activities of both NIH and the pharmaceutical biotechnology industry, our ARLG has established collaborative ties with members of both communities. Our long-term goals are 1) to complete a superiority trial of new anti-infectives (either new agent or new dosing regimen of existing agent) for MDR-Gram negative bacterial infections;2) to define shorter course, narrow-spectrum therapeutic regimens for common infections as a principal means to support stewardship;3) to test a rapid diagnostic that identifies antimicrobial resistance based on genotypic markers in bacteria;and 4) to identify a more effective alternative to vancomycin for MRSA infections. The research agenda reflects our overall strategy of making realistic, incremental steps in early phase studies upon which to build toward more complex transformational trials that will change clinical practice and reduce the impact of antibacterial resistance.
Antibacterial resistance (AR) is one of the world's top health threats. It is a complex, growing problem. Reducing the burden of AR requires a sustained program that simultaneously addresses critical issues from many perspectives. Our goal is to establish an Antibacterial Resistance Leadership Group (ARLG) that will develop, design, implement, and manage a clinical research agenda to increase knowledge of AR, and to reduce the factors that drive its emergence.
|Evans, Scott; Follmann, Dean; Schoenfeld, David et al. (2016) Reply to Phillips, Morris, and Walker. Clin Infect Dis 62:815-6|
|Thaden, Joshua T; Keller, Ashley E; Shire, Norah J et al. (2016) Pseudomonas aeruginosa Bacteremic Patients Exhibit Nonprotective Antibody Titers Against Therapeutic Antibody Targets PcrV and Psl Exopolysaccharide. J Infect Dis 213:640-8|
|Perez, Federico; El Chakhtoura, Nadim G; Papp-Wallace, Krisztina M et al. (2016) Treatment options for infections caused by carbapenem-resistant Enterobacteriaceae: can we apply ""precision medicine"" to antimicrobial chemotherapy? Expert Opin Pharmacother 17:761-81|
|Evans, Scott R; Hujer, Andrea M; Jiang, Hongyu et al. (2016) Rapid Molecular Diagnostics, Antibiotic Treatment Decisions, and Developing Approaches to Inform Empiric Therapy: PRIMERS I and II. Clin Infect Dis 62:181-9|
|Farowski, Fedja; Cornely, Oliver A; Hartmann, Pia (2016) High Intracellular Concentrations of Posaconazole Do Not Impact on Functional Capacities of Human Polymorphonuclear Neutrophils and Monocyte-Derived Macrophages In Vitro. Antimicrob Agents Chemother 60:3533-9|
|Hauck, C; Cober, E; Richter, S S et al. (2016) Spectrum of excess mortality due to carbapenem-resistant Klebsiella pneumoniae infections. Clin Microbiol Infect 22:513-9|
|Wright, Meredith S; Iovleva, Alina; Jacobs, Michael R et al. (2016) Genome dynamics of multidrug-resistant Acinetobacter baumannii during infection and treatment. Genome Med 8:26|
|Spellberg, Brad; Bonomo, Robert A (2016) Editorial Commentary: Ceftazidime-Avibactam and Carbapenem-Resistant Enterobacteriaceae: ""We're Gonna Need a Bigger Boat"". Clin Infect Dis 63:1619-1621|
|Tsalik, Ephraim L; Henao, Ricardo; Nichols, Marshall et al. (2016) Host gene expression classifiers diagnose acute respiratory illness etiology. Sci Transl Med 8:322ra11|
|Ochiai, Toshimitsu; Hamasaki, Toshimitsu; Evans, Scott R et al. (2016) Group-sequential three-arm noninferiority clinical trial designs. J Biopharm Stat :1-25|
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