Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Status:
Terminated
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to
life-threatening colitis. Illness from C. difficile most commonly affects patients in
hospitals and long-term care facilities and typically occurs after a patient has received
antibiotics.
In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to
bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity
of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would
likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer
modeling of CASAD performed by Phillips et al. at Texas A&M University supports this
hypothesis.
The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care
therapy will reduce the duration and severity of diarrhea and other symptoms in patients with
C. difficile infection.
Phase:
Phase 2
Details
Lead Sponsor:
Salient Pharmaceuticals Incorporated
Collaborators:
Scott and White Hospital & Clinic Texas A&M University