PUNCH™ CD Study at Denver Health
A Clinical Trial for the Treatment of Recurrent Clostridium Difficile Infection
Denver Health is one of a select group of sites in the US and Canada participating in the PUNCH™ CD research study, a groundbreaking clinical study of a non-antibiotic therapy for treatment of recurrent Clostridium difficile infection (CDI) that could revolutionize the treatment of this challenging gastrointestinal disease.
CDI is a life-threatening infection characterized by debilitating diarrhea called Clostridium difficile-associated diarrhea, or CDAD. Approximately 700,000 people in the US develop CDI annually with greater than 14,000 deaths.
The purpose of the PUNCH CD study is to assess the safety of RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile-associated diarrhea (CDAD). RBX2660 is a preparation containing live human-derived microbes.
Why is the PUNCH CD Study Important?
Although clinicians have prepared similar products using a variety of methods to treat recurrent Clostridium difficile infection for many years, the PUNCH CD study is the first standardized and commercially prepared microbiota restoration therapy (MRT) for the treatment of recurrent CDAD. As such, it represents a milestone in translating knowledge about the human microbiome into a drug for human use.
PUNCH CD is an open-label, non-randomized study. That means that all clinicians and patients in the study will know that RBX2660 is being given and that all patients in the study will receive RBX2660. Approximately 40 patients will be enrolled in the study, which will continue until all patients have completed six months of follow-up.
Which Healthcare Centers are Participating?
Approximately 20 centers in the US and Canada are participating in the study.
Who is Eligible to Participate?
In brief, the target patient population is adults (≥ 18 years old) with recurrent CDAD who have had:
- At least two recurrences of CDAD (at least three episodes) and have completed at least two rounds of oral antibiotic therapy.
- Have had at least two episodes of severe CDAD resulting in hospitalization.
Why Participate in a Clinical Study?
People participate in clinical studies for many reasons. These include having the opportunity to:
- Receive a new, potentially helpful, research treatment before it is available commercially.
- Receive care at a leading healthcare center during the study.
- Help others with a similar condition.
- Help advance medical knowledge.
Where To Learn More?
For information about the PUNCH CD study at Denver Health contact:
Amy Irwin, DNP, MS, RN
Sponsored by Rebiotix Inc., additional information on the PUNCH CD study can be found at: