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

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.

Study Overview

• Status: Terminated
• Conditions: Diarrhoea, Clostridium Difficile
• Intervention / Treatment: Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: CASAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of Diarrhea	To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stools Per Day	Compare the number of liquid stools per day during treatment period	14 days
Resolution of Abdominal Pain	Compare time to resolution of abdominal pain	14 days
Absence of Relapse	Compare sustained clinical response	42 days
Side-effects and Complications	Compare side-effects and complications	42 days

Collaborators and Investigators

• Sponsor: Salient Pharmaceuticals Incorporated
• Collaborators: Texas A&M University; Scott and White Hospital & Clinic
• Investigators: Principal Investigator: Aarthi Narasimhan, MD, Scott & White Memorial Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: April 1, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (ESTIMATE): April 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 8, 2013
• Last Update Submitted That Met QC Criteria: February 3, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: diarrhea; infection; Clostridium difficile; cramping
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Diarrhea; Clostridium Infections; Physiological Effects of Drugs; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Calcium; Loperamide; Antidiarrheals; Calcium Aluminosilicate
• Other Study ID Numbers: SAL-2011-01PCL-01