Protocol Concept

The ARLG welcomes proposals for clinical studies (e.g., randomized controlled trials, diagnostic studies) to prevent, diagnose, treat, or eradicate antibiotic-resistant bacterial pathogens. Proposals should focus on three priority areas: gram-negative infections, gram-positive infections, and/or diagnostics, described in further detail below. Ideal studies: 1) have the potential to transform medical practice by improving use of antibiotics and/or impacting antibacterial resistance, and 2) would be unlikely to occur without ARLG support.

Applications that propose studies of non-bacterial pathogens, pre-clinical or non-clinical work, or research not directly related to antibiotic resistance will be considered non-responsive (see RFA for more details). Studies of pharmacokinetics, pharmacodynamics in selected populations (e.g., immunocompromised hosts, patients in long-term care settings, neonates, overweight or obese children, underserved populations) and from investigators from diverse backgrounds are encouraged.

The ARLG welcomes ideas from the scientific community. Proposals should be submitted through the submission portal. The types of projects in which ARLG is most interested are described below. This list serves as a guide and is not intended to be comprehensive. Additional studies outside of the scope described below may be considered on a case-by-case basis. To reduce the burden on investigators submitting proposals, the template for protocol concepts has been streamlined into a few essential elements to enable investigators to submit proposals quickly and efficiently.

Investigators who hold a position at a US domestic institution for the duration of the award irrespective of citizenship or visa status are eligible to apply.

The principal investigator may be contacted by the ARLG and invited to submit a more complete application for formal review and consideration for funding. For additional information please contact us at ARLG_Network@dm.duke.edu.

Infections Caused by Gram-negative Bacteria

  • Test strategies for managing gram-negative infections in adults or children caused by drug resistant gram-negative bacilli, including carbapenem-resistant, expanded-spectrum β-lactam-resistant, or fluoroquinolone-resistant bacteria.
  • Evaluate strategies to prevent emergence or dissemination of resistance during treatment of infections caused by gram-negative bacteria.
  • Evaluate use of antimicrobial agents for infections caused by gram-negative bacteria with respect to dose, dosing interval, and duration of therapy in adults or children.

Infections Caused by Gram-positive Bacteria

  • Investigate strategies 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.
  • Evaluate use of antimicrobial agents for infections caused by gram-positive bacteria with respect to dose, dosing interval, and duration of therapy in adults or children.

Diagnostics

  • Evaluate clinical impact of methods/platforms/tests, including microbial targets or host-response markers, which rapidly identify or exclude bacterial infections and/or define associated pathogens, with the goal of directing appropriate (and minimizing inappropriate) treatment. Rapid point-of-care tests which have the potential to guide antibacterial therapy, and implementation science-based activities are encouraged.
  • Appraise clinical value of rapid susceptibility testing methods for cultured bacteria (including in positive blood culture bottles).
  • Selectively design, conduct, analyze, and report scientific studies evaluating the accuracy and utility of diagnostics that address the challenge of antimicrobial resistance. Such studies may support regulatory submissions where industry is unable to support such activities.

 

Please refer to the dropdown list below for more information on how to complete your proposal application.

“When I started out in my career researching new diagnostic approaches for host-gene expression, I often encountered skepticism and received many negative responses from conventional funding sources. However, ARLG recognizes that we cannot continue with the same approach and expect a different solution.

Ephraim Tsalik, MD, MHS, PhD, FIDSA
Danaher Diagnostics, Chief Scientific Officer for ID Diagnostics

 

Submit your Proposal