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:
Salient Pharmaceuticals Incorporated
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
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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
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 Clostridium Infections Signs and Symptoms, Digestive Signs and Symptoms Gram-Positive Bacterial Infections Bacterial Infections |
Antidiarrheals Loperamide Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013