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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570634
Recruitment Status : Terminated (Study was stopped for slow enrollment - only 2 patients, no evaluable results)
First Posted : April 4, 2012
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Scott and White Hospital & Clinic
Texas A&M University
Information provided by (Responsible Party):
Salient Pharmaceuticals Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Diarrhoea, Clostridium Difficile Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection
Study Start Date : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Diarrhea

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Stools Per Day [ Time Frame: 14 days ]
    Compare the number of liquid stools per day during treatment period

  2. Resolution of Abdominal Pain [ Time Frame: 14 days ]
    Compare time to resolution of abdominal pain

  3. Absence of Relapse [ Time Frame: 42 days ]
    Compare sustained clinical response

  4. Side-effects and Complications [ Time Frame: 42 days ]
    Compare side-effects and complications

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570634

United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
Salient Pharmaceuticals Incorporated
Scott and White Hospital & Clinic
Texas A&M University
Principal Investigator: Aarthi Narasimhan, MD Scott & White Memorial Hospital

Responsible Party: Salient Pharmaceuticals Incorporated Identifier: NCT01570634     History of Changes
Other Study ID Numbers: SAL-2011-01PCL-01
First Posted: April 4, 2012    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013
Last Verified: February 2013

Keywords provided by Salient Pharmaceuticals Incorporated:
Clostridium difficile

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Gastrointestinal Agents