Investigator Studies Program (MISP): Clostridium difficile
Effective January 2021, the Clostridium difficile Infections (CDI) Investigator Studies Program (MISP) Committee will accept PROTOCOL submissions within our current areas of interest (AOI) up to May 14, 2021. This is a competitive process that will be conducted by the CDI MISP in 2021. Decisions will be made on the basis of 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:

  • Clinical evaluation of bezlotoxumab efficacy in patients who had a prior CDI episode and are at risk for a new CDI episode. This may include patients who had received bezlotoxumab during treatment of a prior episode.
  • Characterization of bezlotoxumab efficacy and/or impact on quality of life in clinical trials or real-world effectiveness in patients who are receiving antibacterial treatment for CDI and are at high risk for recurrent CDI
    • Solid organ transplant or hemopoietic stem cell transplant patients
    • Patients exposed to broad spectrum antibiotics
  • PK of bezlotoxumab in allogeneic HSCT recipients compared with other immunosuppressed patient populations
  • Characterization of fidaxomicin efficacy in clinical trials or real-world effectiveness in patients at high risk for recurrence of CDI
    • Inflammatory bowel disease patients
    • Solid organ transplant or hemopoietic stem cell transplant patients or other immunocompromised patient populations

For clinical, interventional studies, please complete and submit the PROTOCOL template and GLOBAL CLINICAL FMV BUDGET,template viaVisiontracker, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the CDI MISP Committee.

Critical Activities and Timelines:
Activity 1st Review Cycle
Proposal Submission & Detailed Budget May 14, 2021
MISP-RC Review and selection of proposals by June 15, 2021

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.