PRISM
PRISM evaluates the efficacy and safety of the compound AZD5148 for preventing recurrent Clostridioides difficile infection in adults.
About This Study
Summary
Clostridioides difficile (C. difficile or C. diff) is a bacteria that infects the colon, the longest part of the intestine. Symptoms range from diarrhea to life-threatening intestinal damage. Most C. difficile infections develop after antibiotic use and often occur in older adults who are hospitalized or in long-term care settings. Although antibiotics can kill C. difficile, in 15% – 20% of people, the infection returns within a few weeks. To make things worse, sometimes patients have to endure several cycles of treatment and repeat infection before they're finally clear of C. difficile.
The purpose of the PRISM study is to test the safety and effectiveness of AZD5148, a new medicine for preventing recurrent C. difficile infections in adults. Participants eligible to join the study are randomly assigned (50:50, like a coin toss) to one of two groups: those given AZD5148 or those who receive a pill that looks the same but does not contain AXD5148 (placebo). Neither the lead scientist nor participants can choose or will know which group they are assigned to. Involvement in PRISM includes up to 7 clinic visits as well as weekly and monthly follow-up calls from members of the research team.
To be included in PRISM, participants must be / have
- Adult (18 years or older)
- Qualifying C. difficile infection episode
- Body weight of at least 40 kg (88 lb)
To be included in PRISM, participants must not be / have
- History of inflammatory bowel disease (such as ulcerative colitis, Crohn disease, microscopic colitis)
- Non-C. difficile infection condition routinely leading to loose stool (for example, patients with an ostomy)
- Various surgical procedures, including planned surgery for C. difficile infection within 24 hours of enrollment
- Due to receive more than 25 days of antibacterial drug therapy for the qualifying C. difficile infection episode
- Treatment with a fecal donor transplant, fecal microbiota product, or bezlotoxumab within 180 days before receiving the study product
Keywords
Bacterial infection; C. difficile; Diarrhea
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Official title of study
A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides Difficile Infection in Individuals 18 Years of Age and Above (PRISM)
Funding mechanism
Industry sponsored by AstraZeneca