The ARLG has prioritized four areas of research and solicits proposals for clinical research studies focused on:
Infections caused by Gram-negative bacteria
- Develop and test antimicrobial agents or strategies for Gram-negative infections in adults or children caused by multiple-drug resistance gram-negative bacilli including carbapenem-resistant, expanded-spectrum cephalosporin-resistant, or quinolone-resistant bacteria.
- Evaluate novel agents or strategies to prevent emergence of resistance during treatment of infections caused by Gram-negative bacilli.
- Optimize administration of antimicrobial agents for treatment of Gram-negative infections with respect to dose, dosing interval, and duration of therapy in adults or children.
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 linezolid and daptomycin or other antibiotics alone or in combination with other agents for infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococci (VRE).
- 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.
- Assess antibacterial stewardship strategies for non-use or early discontinuation of antibacterial therapy to reduce emergence and spread of antibiotic resistant bacteria.
- Evaluate transmission dynamics or emergence of carbapenem-resistant, expanded-spectrum cephalosporin-resistant, or quinolone-resistant Gram-negative bacilli in healthcare and community settings.
- Examine strategies (e.g., stewardship, decolonization, probiotics) to prevent occurrence or recurrence or reduce the risk of resistant Gram-negatives, Clostridium difficile infection, VRE, or MRSA.
- Evaluate methods or platforms, which may include biomarkers or host-response markers (e.g., “omics”) to rapidly identify bacterial pathogens and infections. Approaches could include simple and rapid point-of-care diagnostics to detect drug resistance, guide antibacterial therapy, or support clinical trials.
- Evaluate rapid, accurate methods for antimicrobial susceptibility testing of cultured bacteria.
ARLG conducts clinical research studies and clinical trials that will impact the prevention, diagnosis and treatment of antibacterial resistant infections. 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.