The ARLG has prioritized three areas of research and solicits proposals for clinical research studies focused on:
Infections caused by Gram-negative bacteria
- Identify and evaluate novel antimicrobial agents or treatment strategies for infections caused by multidrug-resistant Gram-negative bacilli in adults and children.
- Identify strategies to optimize the administration of antibiotics for the treatment of Gram-negative infections with respect to dose, interval, and duration of therapy in adults and children.
- Evaluate novel strategies to prevent the emergence of resistance in Gram-negative bacilli.
Infections caused by Gram-positive bacteria
- Investigate strategies or therapies, including narrow-spectrum oral antimicrobials, for treatment of infections predominantly caused by Gram-positive bacteria, including skin and soft tissue infections, bone and joint infections, and bacteremia in adults and children.
- Compare the effectiveness of novel agents alone or in combination with other agents for infections caused by methicillin-resistant Staphylococcus aureus or vancomycin resistant enterococci.
- Optimize administration of antimicrobial agents for treatment of Gram-positive infections with respect to dose, dosing interval, and duration of therapy in adults or children.
Diagnostic evaluations of interest to the ARLG include assessments of assay test characteristics, use of diagnostics to enhance clinical trial enrollment, and studies designed to measure the impact of antimicrobial resistance (AMR) diagnostics on clinical outcomes and optimal antibiotic use.
Specifically, the ARLG will:
- Assess new methods or platforms designed to rapidly detect and identify bacterial pathogens, resistance determinants, virulence factors, and/or predict antimicrobial susceptibility profiles. Diagnostics may be simple point-of-care tests or advanced technologies for clinical laboratories. Studies may include AMR detection direct from clinical specimens or cultured isolates.
- Examine novel biomarkers and/or gene expression profiles as an approach to detect and diagnose infection, or to discriminate between infectious versus non-infectious etiologies.
- Study educational initiatives, machine learning algorithms, and/or the use of the electronic medical record to improve knowledge about AMR and optimize diagnostic test utilization/interpretation with a view towards improving the use of antibiotics.
ARLG conducts clinical research studies and clinical trials that will impact the prevention, diagnosis, and treatment of infections caused by antibiotic-resistant bacteria. The ARLG Scientific Agenda gives the highest priority to the top antibacterial resistance threats identified by U.S. and international expert bodies, such as the CDC and the WHO. Studies are generalizable to the U.S. population and include, but are not limited to:
- Early clinical evaluation of new antibacterial therapeutic and prophylactic products, including small molecule antibiotics, monoclonal antibodies, applications of microbial ecology approaches, bacteriophage-based products, and vaccines.
- Comparative effectiveness trials.
- Strategy trials to optimize currently licensed antibacterials (e.g. dose, duration, clinical algorithms, need for drug, combinations) to reduce the risk of resistance.
- Validation studies of new diagnostic tests using clinical isolates or specimens, including to support regulatory submissions.
- Clinical utility studies of diagnostic tests to determine the impact of approved tests on patient- and facilities-level outcomes and prescribing behavior.
- Molecular epidemiological studies to provide data on the associations between patient characteristics, clinical outcomes, and resistant genotypes/phenotypes, and to inform future interventional trials.
- Pharmacokinetic (PK) and pharmacodynamic (PD) studies.
- Strategies to better manage the consequences of broad spectrum antimicrobial use, e.g. Clostridioides difficile infections.
- Collaborations with industry and academic groups as needed, both domestically and internationally, to guide optimal clinical trial designs, answer key questions that cannot be addressed alone, and strengthen a community of antibacterial resistance researchers that can contribute to the US government’s response to emerging resistant threats.
The following types of studies are beyond the scope of the ARLG:
- Studies of infection control programs and broad antimicrobial stewardship interventions, which are supported by other government agencies. However, innovative statistical analyses of ongoing stewardship efforts are permitted.
- Studies focused on parasites, viruses, and mycobacteria, which are supported by other NIAID programs.