PROCLAIM is a clinical trial for adults aged 50 years old and older who been diagnosed with a C. difficile infection (CDI). The PROCLAIM Trial plans to enroll 440 participants across 3 academic medical centers who will receive either misoprostol or matching placebo (a pill that looks like the study medication but does not have any medication in it).
C. difficile infections are emerging as one of the most common healthcare-associated infections, in the United States, it comprises approximately 17.1% of hospital-associated infections affecting 500,000 individuals annually. C. difficile infection (CDI) ranges in severity from mild diarrhea to severe colitis (sometimes resulting in septic shock and/or death).
In addition, CDI has a high tendency to recur following treatment. First clinical recurrence of infection occurs in about 25% of patients initially treated with antibiotic therapy (rate of recurrence can be much higher among those ≥50 years of age). Once a first recurrence has occurred, the risk for future recurrences exceeds 40% (again, higher in older adults, ≥50 years of age). The problem of recurrent CDI (rCDI) is a significant one, negatively impacting quality of life. There are patients for whom the cycle of recurrences does not remit.
Misoprostol is FDA-approved for chronic use in the prevention of gastric ulcers given its established mucosal protective properties and inhibitory effects on gastric acid.
This study is a randomized, double-blind, placebo-controlled study which means that participants will either receive pills containing the study drug, misoprostol, or sugar pills (placebo) that look like the study drug. Randomized means that no one is able to choose who receives the study drug and who receives placebo, so it is up to chance (like flipping a coin). Double-blind means that you, the study doctor and the study team will not know which pill you receive.
Participants will take 2 study pills twice a day for 14 days. Study participation will last about 10 weeks and will include 3 in-person study visits (additional visits will be required if symptoms of C. difficile recurrence occur) and weekly phone calls. Collection of labs and information regarding your health will occur at these visits.