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

NCT01570634 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-03-08

Study results available
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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

DRUG

Calcium Aluminosilicate Anti-Diarrheal (CASAD)

CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up

Sponsors & Collaborators

  • Scott and White Hospital & Clinic

    collaborator OTHER

  • Texas A&M University

    collaborator OTHER

  • Salient Pharmaceuticals Incorporated

    lead INDUSTRY

Principal Investigators

  • Aarthi Narasimhan, MD · Scott & White Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570634 on ClinicalTrials.gov