ANTIFUNGAL :Noxafil/Posaconazole

  1. Clinical experience with NOXAFIL IV in the primary treatment of invasive aspergillosis in high risk patients (hematopoietic stem cell transplant patients (including patients with GVHD), neutropenic patients with hematologic malignancies post –chemotherapy, solid organ transplant recipients and other immunosuppressed patients (including use in the ICU setting and use in patients recently hospitalized with COVID).
  2. Clinical experience with NOXAFIL (with either the oral tablet, and/or IV solution) either in prophylaxis or treatment (including salvage treatment) of hematopoietic stem cell transplant patients (including patients with GVHD), neutropenic patients with hematologic malignancies post –chemotherapy, solid organ transplant recipients and other immunosuppressed patients (including use in the ICU setting).
  3. Preclinical studies including global and regional azole susceptibility surveys, mechanisms of azole resistance, in vitro and in vivo models of relevant invasive mold infections, and PK/PD assessments in relevant invasive mold infections
  4. PK/PD assessment of NOXAFIL (IV, tablet, IV-to-tablet) in special populations including pediatric and adult patients with GVHD, neutropenic patients with hematological malignancies post-chemotherapy, solid organ transplants recipients and other immunosuppressed patients (including use in the ICU setting)
  5. Epidemiological studies evaluating burden of disease of Candida and Aspergillus or other rare mold infections in high-risk patient populations
  6. Pharmacoeconomic, health services and/or outcomes research studies in approved indications
  7. Antifungal Stewardship initiatives that explore the utility of NOXAFIL