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The Focus Areas: III. Research

Antimicrobial resistance is among the most challenging problems in microbiology, clinical medicine, and public health. Antimicrobial resistance is not one problem, but an overarching term for an array of problems inherent in the evolution of microbes and influenced by antimicrobial use. Basic and clinical research provides the fundamental knowledge necessary to develop appropriate responses to antimicrobial resistance emerging and spreading in hospitals, communities, farms, and the food supply. Major scientific accomplishments throughout the years have contributed much to the understanding of the fundamental biological processes of AR within microbes and the resulting impact on humans, animals, and the environment. This knowledge base provides us the opportunity to influence these processes and outcomes.

Because of its broad scope, the U.S. research community has a major contribution to make in meeting the goals the AR Task Force has set forth. The research and development of diagnostic tests, new antimicrobial agents, novel therapeutic products, and vaccines and other preventive approaches in response to AR is a multistep process that begins with basic research discoveries and ends with the availability and use of a new product or implementation of a process. Along this pathway three areas need to be addressed: the identification of gaps and needs in the molecular and cellular understanding of resistance, the infrastructure to support a robust research community, and a means for moving research findings into the development of new products.

The Interagency Task Force has worked with representatives from the public and private sector to identify important research needs in microbial physiology, ecology, genetics and mechanisms of resistance. Existing gaps in knowledge and understanding should be addressed to augment the federal and private sector response to the overall problem. Efforts are underway to build and enhance the field of AR research, through increased focus, recognition, and collaboration. The aim is to develop a research infrastructure to support a critical mass of AR researchers who will interact, exchange information, and stimulate new discoveries. In order to move novel ideas arising in the research laboratory to useful products or approaches, support of the underlying infrastructure to study and test products and a mechanism to transition to industrial partners is necessary.

This effort will involve federal agencies that conduct, support and promote basic and clinical research in academia and industry and will involve prioritizing needs, identifying key opportunities, recruiting new investigators to the field, and making responsible use of resources to address AR problems.

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A. Issue: Specific scientific gaps remain in the understanding of microbial physiology, ecology, genetics and mechanisms of resistance.

1.Goal: Identify gaps and address existing research needs and identify new ones.

a. Action Items

  1. Additional research, including high risk and high payoff research in nontraditional fields, is needed to enhance the understanding and assess the impact of:
    • Mechanisms of AR emergence, acquisition, spread, persistence, and decline, with special regard to multidrug resistant organisms;
    • Emergence and transfer of resistance genes among microorganisms in vivo, including epidemiologic factors;
    • Microbial ecology and the role of normal flora as a repository of resistance factors, as well as the use of susceptible bacterial populations in the control of antimicrobial resistance;
    • Effects of preventive, therapeutic, growth-promoting agents and residues of agents in the environment on the microbiota of animals, plants, soil, and aquatic environments;
    • Host factors and immune modulators (e.g., cytokines) in clinical resistance to treatments for opportunistic infections;
    • The determinants of colonization and infection with drug-resistant pathogens; and
    • Variations in antimicrobial use patterns that may affect the emergence and spread of resistance and the outcome of treatment, such as:
      • Differences in duration and dosage in the administration of antimicrobial agents;
      • Prophylactic use of antimicrobial (including antibacterial and antifungal) agents; Drug combinations used to treat resistant organisms; and
      • The rotation (cycling) of antimicrobial drugs and other similar changes in selection and use of drug classes.
        Coordinator: NIH;
        Collaborators: CDC, FDA, DVA, USDA, EPA, DoD
        Timeline: Initiated
  2. Conduct further government-wide assessments with external input on the scope and composition of AR research to identify research opportunities.
    Coordinators: NIH, CDC, FDA, USDA;
    Collaborators: DoD, DVA, AHRQ, EPA, HCFA
    Timeline: Initiated

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B. Issue: The existing research infrastructure needs to ensure a critical mass of researchers in AR and related fields.

1. Goal: Augment the scientific research infrastructure.

a. Action Items

  1. Work with the appropriate peer review structures to ensure that the requisite expertise is applied to the review process to facilitate funding of quality AR research.
    Coordinators: NIH, DVA, FDA
    Timeline: Begin in one to two years
  2. TOP PRIORITY ACTION ITEM - Provide to the research community genomics and other powerful technologies to identify targets in critical areas for the development of new rapid diagnostics methodologies, novel therapeutics, and interventions to prevent the emergence and spread of resistant pathogens. Examples include tools such as microbial genome sequences, information on comparative genomics, DNA chip technology, informatics, and assistance in the application and use of these tools.
    Coordinator: NIH; Collaborators: DoD, USDA, FDA
    Timeline: Initiated
  3. Encourage sharing of AR data between industry and the research community, including genomics and other technologies.
    Coordinator: NIH;
    Collaborators: DoD, USDA, FDA
    Timeline: Begin in three to five years

2. Goal: Develop a critical mass of researchers in AR.

a. Action Items

  1. Bring new researchers into the field, by utilizing appropriate strategies such as training and research opportunities.
    Coordinator: NIH; Collaborators: CDC, FDA, USDA, DoD, DVA
    Timeline: Initiated
  2. Organize conferences that address research issues relating to AR.
    Coordinator: NIH;
    Collaborators: CDC, USDA, FDA, DVA, DoD, AHRQ
    Timeline: Initiated

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C. Issue: Special efforts are needed to translate research findings into medically useful products for human and agricultural/veterinary use, such as novel antimicrobial therapeutics, diagnostic tests, vaccines and other tools for preventing AR emergence and spread.

1. Goal: Address the governmental role in translating novel ideas into new clinically relevant products, focusing on gaps not filled by pharmaceutical industry and other nongovernment groups.

a. Action Items

  1. Explore the need to encourage preclinical studies on the toxicology, pharmacokinetics, and pharmacodynamics of novel therapeutic agents for the treatment of multidrug-resistant pathogens and facilitate the transition of potential products from preclinical to clinical studies leading to development by industry of novel therapeutic agents.
    Coordinator: NIH;
    Collaborators: DoD, DVA, FDA, USDA
    Timeline: Begin within one to two years
  2. TOP PRIORITY ACTION ITEM - In consultation with academia and the private sector, identify and conduct human clinical studies addressing AR issues of public health significance that are unlikely to be studied in the private sector, such as:
    • Novel therapies;
    • Existing antimicrobials administered in treatment regimens and combinations that may not be included in approved indications and dosing schedules; and
    • Other products and practices relevant to the control and treatment of antimicrobial-resistant pathogens including devices, diagnostics, antimicrobial soaps, disinfectants, etc.
      Coordinator: NIH;
      Collaborators: CDC, DVA, DoD, FDA
      Timeline: Begin within one to two years

2. Goal: Develop rapid, inexpensive, point-of-care diagnostic methods to facilitate appropriate use of antimicrobials.

a. Action Items

  1. TOP PRIORITY ACTION ITEM - Identify, develop, test, and evaluate new rapid diagnostic methods for human and veterinary uses with partners including academia and the private sector. Such methods should be accurate, affordable, and easily implemented in routine clinical settings and may include:
    • Tests for resistance genes that are associated with drug resistance, including nonculture specimens;
    • Rapid point-of-care diagnostics for patients with viral respiratory infections and clinical syndromes such as otitis media, sinusitis, and pneumonia; and
    • Rapid methods for detecting drug resistance among fungi, parasites, viruses, and mycobacteria.
      Coordinators: NIH, FDA;
      Collaborators: DoD, USDA, CDC, AHRQ, DVA
      Timeline: Initiated

3. Goal: Develop new products and strategies to prevent and treat colonization and infection with resistant organisms in patients, prevent transmission of resistant infections in the community, and prevent AR emergence

a. Action Items

  1. TOP PRIORITY ACTION ITEM - Encourage basic and clinical research in support of the development and appropriate use of vaccines in human and veterinary medicine in partnership with academia and the private sector. Vaccines are needed to:
    • Prevent viral infections that predispose patients to and are difficult to differentiate from bacterial infection and are presumptively treated with antibacterial agents (e.g., influenza virus);
    • Prevent colonization, infection, and transmission of resistant organisms such as enterococci and staphylococci; and
    • Prevent common bacterial infections (such as S. pneumoniae, nontypable Haemophilus influenzae) to reduce antibacterial use.
      Coordinators: NIH, FDA;
      Collaborators: CDC, DoD, DVA, USDA Timeline: Initiated
  2. Encourage basic and clinical research in support of novel approaches to preventing or treating infections with resistant organisms that occur in humans and animals by partnering with academia and the private sector. Novel approaches may include:
    • Bacteriophage therapy;
    • Active (vaccine) and passive (antibody, hyperimmune globulin) immunization;
    • Host-derived antimicrobial agents;
    • Nonantibiotic antimicrobials and nonchemical approaches with broad or nonspecific anti-infective activities (e.g., defending and nonspecific immunostimulants, such as defensins, ribozymes, etc.); and
    • Microbial ecology (probiotics, direct fed microbials, etc.).
      Coordinator: NIH;
      Collaborators: DoD, DVA, FDA, USDA, CDC
      Timeline: Initiated

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