Who Seeks a Fecal Microbiota Transplant for Recurrent C. difficile Infection?: Patient Profile of the PUNCH CD Study
Methods: The PUNCH CD study enrolled a range of patients with recurrent CDI who were: ≥ 18 years with recurrent CDI who had at least two recurrences after a primary episode and completed at least two rounds of standard-of-care oral antibiotic therapy or had at least two episodes of severe CDI resulting in hospitalization.
Results: A total of 40 subjects were enrolled at 11 US centers with 34 subjects receiving treatment with RBX2660. Study centers were geographically and functionally diversified to include academic health centers located in major metro areas, community-based specialty clinics, and an integrated health system serving a sparsely populated largely rural state. Baseline characteristics of the 34 treated subjects were: mean age: 66.8 years (range 26.7 to 89.6 years); female (67.6%, n=23); Caucasian (94.2%, n=32) with a mean BMI 24.4 (range: 15.0 to 37.0). Comorbid illnesses included: gastrointestinal (61.8%, n=21), cardiovascular (55.9%, n=19), genitourinary (69.2%, n=18), and psychiatric (28.1%, n=9). A total of 76% (n=26) of subjects were not working (mostly retired) while 24% (n=8) reported working full- or part-time with no restrictions.
Conclusion: The population of patients seeking treatment in this study of next-generation FT drug was primarily Caucasian, elderly and female with multiple comorbidities. These demographics highlight populations with recurrent CDI and increase the awareness of opportunities to diversify enrollment in trials for recurrent CDI.
ReBiotix: Investigator and Scientific Advisor, Consulting fee and Research support
Merck: Consultant and Investigator, Research support
sanofi pasteur: Consultant and Investigator, Consulting fee and Grant recipient
merck: Consultant and Grant Investigator, Consulting fee and Research support
cubist: Consultant and Investigator, Consulting fee and Research support
C. Griesbach, None
M. K. Sobcinski, Rebiotix Inc: Employee, Salary
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