NCT01570634

Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection

Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Salient Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhoea, Clostridium Difficile

Interventions

Type	Name	Description
DRUG	Calcium Aluminosilicate Anti-Diarrheal (CASAD)	CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-04-04
• Last updated: 2013-03-08
• Results posted: 2013-03-08

Locations

1 site across 1 country: United States