An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treated for C. Difficile Infections
 
The primary objective of this observational study was to estimate the 90-day response rates to treatment for C. difficile infections (CDI). This included treatment success, recurrence, and complications (including perforation, toxic megacolon, transfer to ICU
with CDI, and death from CDI related cause) in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. Secondary objectives were to
describe the clinical characteristics of C. difficile infections and to assess risk factors for outcomes over a 90-day follow-up period.
 
Patients who developed CDI within 2 years after transplantation were enrolled and followed prospectively for 90 days after enrollment. Patients that were currently being treated for
a first episode of CDI after transplant could be enrolled in the study. The date of diagnosis was defined as the date of sample collection for positive toxin detection.
 
The planned sample size for the study was 150 participants.  The participants were enrolled by 15 sites in the United States, Europe, and Argentina. The study closed for enrolment in July 2018.
 
The study was conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). INSIGHT includes a Statistical and Data Management
Center (SDMC) and Operations Center at the University of Minnesota and four International Coordinating Center (ICCs). 

The study was sponsored by University of Minnesota and funded in part by Merck & Co., Inc and Astellas Pharma.

More information about the study