Anti-Infectives, Sterile Injectables and Hospital Products Areas of Interest

Research areas to be considered for funding include:

• Predictors of hematological response to Immunosuppressive Therapy (IST)
• Treatment outcomes improvement in different subpopulations of patients with AA
• Real World Evidence (RWE) in AA, especially for IST/Antithymocyte Immunoglobulin
• Patient Reported Outcomes
• Therapeutic options using IST based on Antithymocyte Immunoglobulin
• Improving treatment outcomes in vulnerable subpopulations
• Improving the diagnosis of AA
• Posology adjustment for specific vulnerable populations
• Conditioning regimen of bone marrow transplantation using Antithymocyte Immunoglobulin

NOTE: Drug supply will only be considered on a case-by-case basis.

Out of scope:

• Active Drug substance for clinical use
• Protocols which include product reformation or compounding
• Protocols which request placebo formations

Proposals should consider the impact of interventions on a variety of outcome categories, including but not limited to clinical outcomes, population outcomes, collateral damage (e.g., antimicrobial resistance, toxicity/adverse effects, selection of pathogenic organisms such as C. difficile), process measures, and costs. Proposals should consider that antimicrobials include antibiotics, antifungals, and antivirals. Proposals that include at least one of the following areas of interest, in no particular order, will be prioritized:

• Implementation science and behavioral science related to effectiveness of antimicrobial stewardship interventions
• Outcomes associated with the following mechanisms to enhance antimicrobial stewardship:
  • Innovative digital tools
  • Rapid diagnostics
  • Patient engagement
  • Involvement of allied healthcare providers (e.g., nurses, microbiologists, community health workers, dentists, etc.)
• Antimicrobial stewardship in resource-limited settings and/or special patient populations (e.g., pediatrics, critically ill, hematology/oncology, OPAT, etc.)
• Antimicrobial stewardship interventions to reduce health disparities in infectious diseases management

Aztreonam-avibactam (ATM-AVI)

Research areas to be considered for support:

• In-vitro data generation for Multidrug Resistant Gram Negative Bacteria-
  • Susceptibility (as compared to other Rx options) and molecular patterns- for Stenotrophomonas maltophilia and Enterobacterales
  • Inoculum effect- for Stenotrophomonas maltophilia and Enterobacterales
  • Checkerboard synergy studies for combination therapy- including but not limited to Pseudomonas aeruginosa
  • Hollow fibre model studies for activity of ATM-AVI in MBL producing Stenotrophomonas maltophilia
• PK/PD data
  • Renal replacement therapy including but not limited to CRRT 
  • Tissue penetration data- lungs, meninges, Skin and Soft tissue, Bone and joints (e.g. microdialysis methodology)
  • ECMO patients
• RWE on the clinical outcomes with ATM-AVI
• Impact on microbiota with ATM-AVI vs comparators

Ceftaroline fosamil

Research areas to be considered for support:

• Activity vs. resistant pathogens
• Prevalence of resistant gram + pathogens (e.g., penicillin NS (non-susceptible), macrolide resistant and/or ceftriaxone resistant Streptococcus pneumoniae)
• Monitor emergence of ceftaroline resistant strains: support local in vitro surveillance to supplement data
• Tissue penetration
• Bacteremia
• Severe community-acquired pneumonia (CAP) (incl. MRSA- methicillin resistant staphylococcus aureus)
• Diabetic foot infections (DFI), surgical site infections (SSI) with complications (secondary osteo), resistant pathogens, pediatrics, meningitis, endocarditis, cystic fibrosis

Ceftazidime-avibactam

Research areas to be considered for support:

• Microbiology and surveillance studies, invitro synergy studies with other antibiotics
• Clinical efficacy 
• Tissue penetration
• Continuous infusion

Target populations:

• ICU patients
• Patients with comorbidities
• Patients with previous antibiotic exposure in <6 months 
• Recent hospitalization

Out of scope:

• Patients with confirmed gram positive infections

Isavuconazole

Research areas to be considered for support:

• Improve awareness of invasive mold infections
• Improve clinical diagnosis, new surrogate markers and diagnostic strategies, and improve mold infections laboratory capabilities
• Isavuconazole real-world data. Experience using isavuconazole, epidemiology of IFI and health disparity opportunities. Use in ECMO, renal and hepatic dysfunction, and switch from other azoles
• New uses for isavuconazole. prophylaxis, combination therapy, oral switch in candidiasis, in cryptococcus meningitis, and in chronic disease
• Disparity and equity. Vulnerable populations or/and neglected diseases as well as supporting minority mycologists in low-income countries

Target populations:

• Hematological malignancy
• Intensive care units
• Emerging patients at risk such with influenza, covid19 and new chemotherapies
• Chronic IFI disease and chronic pulmonary disease

Out of scope:

• Primary treatment of candidiasis
• Endemic mycoses: All studies in endemic mycoses (HIV and crypto after animal model, cocci animal model)

Invasive Fungal Infections Awareness and Diagnosis

Research areas to be considered for support:

• Improve awareness of invasive fungal infections (yeasts and molds)
• Improve clinical diagnosis, new surrogate markers and diagnostic strategies, and improve invasive fungal infections (yeasts and molds) laboratory capabilities
  • use of diagnostic tools, images or other techniques to enhance the knowledge in the early diagnosis of invasive fungal infections