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.
|Anesi, Judith A; Lautenbach, Ebbing; Nachamkin, Irving et al. (2018) Poor clinical outcomes associated with community-onset urinary tract infections due to extended-spectrum cephalosporin-resistant Enterobacteriaceae. Infect Control Hosp Epidemiol 39:1431-1435|
|Cheng, Yao-Wen; Phelps, Emmalee; Ganapini, Vincent et al. (2018) Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. Am J Transplant :|
|El Chakhtoura, Nadim G; Saade, Elie; Iovleva, Alina et al. (2018) Therapies for multidrug resistant and extensively drug-resistant non-fermenting gram-negative bacteria causing nosocomial infections: a perilous journey toward 'molecularly targeted' therapy. Expert Rev Anti Infect Ther 16:89-110|
|Rieger, C T; Liss, B; Mellinghoff, S et al. (2018) Anti-infective vaccination strategies in patients with hematologic malignancies or solid tumors-Guideline of the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO). Ann Oncol 29:1354-1365|
|Wang, Tiffany; Kraft, Colleen S; Woodworth, Michael H et al. (2018) Fecal Microbiota Transplant for Refractory Clostridium difficile Infection Interrupts 25-Year History of Recurrent Urinary Tract Infections. Open Forum Infect Dis 5:ofy016|
|Gopalsamy, Srinivasa Nithin; Woodworth, Michael H; Wang, Tiffany et al. (2018) The Use of Microbiome Restoration Therapeutics to Eliminate Intestinal Colonization With Multidrug-Resistant Organisms. Am J Med Sci 356:433-440|
|Evans, Scott R; Follmann, Dean; Liu, Ying et al. (2018) Sequential Multiple Assignment Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS). Clin Infect Dis :|
|Tamma, Pranita D; Pierce, Virginia M; Cosgrove, Sara E et al. (2018) Can the Ceftriaxone Breakpoints Be Increased Without Compromising Patient Outcomes? Open Forum Infect Dis 5:ofy139|
|Kanwar, Anubhav; Marshall, Steven H; Perez, Federico et al. (2018) Emergence of Resistance to Colistin During the Treatment of Bloodstream Infection Caused by Klebsiella pneumoniae Carbapenemase-Producing Klebsiella pneumoniae. Open Forum Infect Dis 5:ofy054|
|Springer, Jan; White, P Lewis; Kessel, Johanna et al. (2018) A Comparison of Aspergillus and Mucorales PCR Testing of Different Bronchoalveolar Lavage Fluid Fractions from Patients with Suspected Invasive Pulmonary Fungal Disease. J Clin Microbiol 56:|
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