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

Primary Purpose

Diarrhoea, Clostridium Difficile

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcium Aluminosilicate Anti-Diarrheal (CASAD)
Sponsored by
Salient Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhoea, Clostridium Difficile focused on measuring Clostridium difficile, infection, diarrhea, cramping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scott & White Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label CASAD

Arm Description

Treatment with CASAD for 14 days

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2012
Last Updated
February 3, 2013
Sponsor
Salient Pharmaceuticals Incorporated
Collaborators
Scott and White Hospital & Clinic, Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT01570634
Brief Title
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Official Title
Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped for slow enrollment - only 2 patients, no evaluable results
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salient Pharmaceuticals Incorporated
Collaborators
Scott and White Hospital & Clinic, Texas A&M University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea, Clostridium Difficile
Keywords
Clostridium difficile, infection, diarrhea, cramping

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label CASAD
Arm Type
Experimental
Arm Description
Treatment with CASAD for 14 days
Intervention Type
Drug
Intervention Name(s)
Calcium Aluminosilicate Anti-Diarrheal (CASAD)
Other Intervention Name(s)
CASAD
Intervention Description
CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
Primary Outcome Measure Information:
Title
Resolution of Diarrhea
Description
To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Stools Per Day
Description
Compare the number of liquid stools per day during treatment period
Time Frame
14 days
Title
Resolution of Abdominal Pain
Description
Compare time to resolution of abdominal pain
Time Frame
14 days
Title
Absence of Relapse
Description
Compare sustained clinical response
Time Frame
42 days
Title
Side-effects and Complications
Description
Compare side-effects and complications
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aarthi Narasimhan, MD
Organizational Affiliation
Scott & White Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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