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

This study has been terminated.
(Study was stopped for slow enrollment - only 2 patients, no evaluable results)
Sponsor:
Collaborators:
Scott and White Hospital & Clinic
Texas A&M University
Information provided by (Responsible Party):
Salient Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01570634
First received: April 1, 2012
Last updated: February 3, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Diarrhoea, Clostridium Difficile
Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by Salient Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Resolution of Diarrhea [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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:
  • Stools Per Day [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Compare the number of liquid stools per day during treatment period

  • Resolution of Abdominal Pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Compare time to resolution of abdominal pain

  • Absence of Relapse [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Compare sustained clinical response

  • Side-effects and Complications [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Compare side-effects and complications


Enrollment: 2
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570634

Locations
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
Investigators
Principal Investigator: Aarthi Narasimhan, MD Scott & White Memorial Hospital
  More Information

No publications provided

Responsible Party: Salient Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01570634     History of Changes
Other Study ID Numbers: SAL-2011-01PCL-01
Study First Received: April 1, 2012
Results First Received: December 29, 2012
Last Updated: February 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Salient Pharmaceuticals Incorporated:
Clostridium difficile
infection
diarrhea
cramping

Additional relevant MeSH terms:
Diarrhea
Infection
Signs and Symptoms
Signs and Symptoms, Digestive
Antidiarrheals
Loperamide
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014