Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
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.
|Diarrhoea, Clostridium Difficile||Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection|
- Resolution of Diarrhea [ Time Frame: 42 days ]To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).
- Stools Per Day [ Time Frame: 14 days ]Compare the number of liquid stools per day during treatment period
- Resolution of Abdominal Pain [ Time Frame: 14 days ]Compare time to resolution of abdominal pain
- Absence of Relapse [ Time Frame: 42 days ]Compare sustained clinical response
- Side-effects and Complications [ Time Frame: 42 days ]Compare side-effects and complications
|Study Start Date:||March 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Open Label CASAD
Treatment with CASAD for 14 days
Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)
CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
Other Name: CASAD
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570634
|United States, Texas|
|Scott & White Memorial Hospital|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Aarthi Narasimhan, MD||Scott & White Memorial Hospital|