Clinical trial NCT01570634: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diarrhoea, Clostridium Difficile
Keywords: Clostridium difficile
infection
diarrhea
cramping
Lead sponsor: Salient Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Scott and White Hospital & Clinic
name: Texas A&M University
First posted: 2012-04-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Resolution of Diarrhea
timeFrame: 42 days
Secondary outcomes:
measure: Stools Per Day
timeFrame: 14 days
measure: Resolution of Abdominal Pain
timeFrame: 14 days
measure: Absence of Relapse
timeFrame: 42 days
measure: Side-effects and Complications
timeFrame: 42 days
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
affiliation: Scott & White Memorial Hospital
name: Aarthi Narasimhan, MD
role: PRINCIPAL_INVESTIGATOR
References: