Investigator Studies Program (MISP): Antifungal
Effective January 2022, the Antifungal Investigator Studies Program (MISP) Committee will accept protocols within our current areas of interest (AOI) per the review cycles noted below. This is a competitive process that will be conducted by the Antifungal MISP Committee in 2022. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to Investigator Studies Program Committee:

Noxafil

  1. Clinical experience with IV NOXAFIL 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) in US, EU and Japan regions.

  2. Clinical experience with NOXAFIL IV and powder for oral suspension (PFS) including PK studies in the prevention of invasive fungal infections in high-risk pediatric patients (2 years of age and older with weight < 40 kg) (including hematopoietic stem cell transplant patients (including patients with GVHD), neutropenic patients with hematologic malignancies post –chemotherapy, solid organ transplant recipients and other immunosuppressed patients) in the US and EU regions

  3. 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) in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

  4. 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 in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

  5. 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) in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

  6. Epidemiological studies evaluating burden of disease of Candida and Aspergillus or other rare mold infections in high-risk patient populations in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

  7. Pharmacoeconomic, health services and/or outcomes research studies in approved indications in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

  8. Antifungal Stewardship initiatives that explore the utility of NOXAFIL in the Middle East, Eastern Europe (tablet and IV where available) China and Japan

Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The protocols will be collectively reviewed and selected by the Antifungal MISP Committee.

Critical Activities and Timelines:
Activity 1stReview Cycle 2ndReview Cycle
Protocol Submission with Detailed Budget April 11, 2022 October 10, 2022
Review Committee Meeting May 10, 2022 November 7, 2022


MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.

Support Material

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