Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal for Treatment of Clostridium Difficile Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | March 2012 |
| End Date: | December 2012 |
| Contact: | Aarthi Narasimhan, MD |
| Email: | ANARASIMHAN@swmail.sw.org |
| Phone: | 9255771038 |
Proof-of-Concept, 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.
Inclusion Criteria:
- C. difficile-associated diarrhea at the time of enrollment
- 18 years old and up
- Ability to take oral medications
- Negative urine pregnancy test for women of childbearing age
- Must have the ability to understand and the willingness to provide a written informed
consent to participate in the study
Exclusion Criteria:
- History of known allergy to silicates
- Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or
bowel perforation
- Patients with hypotension (systolic blood pressure < 90 mm Hg) or septic shock
requiring pressors
- Patients with other known causes of diarrhea or colitis
- Pregnancy or lactation
- History of significant neurological or psychiatric disorders that would impede giving
consent, treatment, or follow up
- Participation in any other study where the subject is actively taking investigational
medication within the last 30 days
- More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug
for the current C. difficile diagnosis. Administration of metronidazole or oral
vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some
patients may be experiencing a relapse of C. difficile.
- Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment
of C. difficile prior to or added to the subject's standard-of-care treatment
regimen. Use of intravenous vancomycin is not exclusionary.
We found this trial at
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Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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