Investigator Studies Program (MISP): Clostridium difficile
Effective October 2018, the Clostridium difficile Infections (CDI) Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 8, 2019 for the first review cycle, and up to April 3, 2019 for the second review cycle. This is a competitive process that will be conducted by the CDI MISP in 2019. 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 following areas are of interest to Investigator Studies Program Committee:

  • Studies to develop or validate a bedside scoring system to predict the risk of CDI recurrence by identifying easily ascertained clinical characteristics and/or biomarkers from patients with primary or first recurrence of CDI who are at high risk for subsequent CDI recurrence
  • 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. Examples include but are not limited to:
    • Patients needing antibiotics known to be associated with a high risk for CDI
    • Residents in long-term care facilities
  • Characterization of bezlotoxumab efficacy and tolerability or real-world effectiveness in patients who are receiving antibacterial treatment for CDI and are at high risk for recurrent CDI
    • Inflammatory bowel disease patients
    • Solid organ transplant or hemopoietic stem cell transplant patients
    • Dialysis patients
    • Cirrhotic patients
    • Immunocompromised patients
    • Patients exposed to broad spectrum antibiotics
    • Patients who failed FMT, in place of FMT or where FMT is not indicated
  • Characterization of bezlotoxumab efficacy in patients at high risk for CDI recurrence stratified by genetic biomarker status (SNP rs2516513)
  • Characterization of fidaxomicin efficacy and/or tolerability 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
    • Dialysis patients
    • Cirrhotic patients
    • Immunocompromised patients


Please complete a full protocol and detailed budget via Visiontracker, 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 2nd Review Cycle
Full Proposal Submission & Detailed Budget March 8, 2019 June 7, 2019
MISP-RC Review and selection of proposals by April 3, 2019 June 27, 2019


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.