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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)

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

NCT ID

NCT01570634

First Posted

April 1, 2012

Last Updated

February 3, 2013

Sponsor

Salient Pharmaceuticals Incorporated

Collaborators

Scott and White Hospital & Clinic, Texas A&M University

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

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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