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

NCT01570634 | Terminated Phase 2 Results DMC

• 1 other identifier: SAL-2011-01PCL-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea, Clostridium Difficile

Keywords

Clostridium difficile; infection; diarrhea; cramping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Stools Per Day

  14 days

• Resolution of Abdominal Pain

  14 days

• Absence of Relapse

  42 days

• Side-effects and Complications

  42 days

Study Arms (1)

Open Label CASAD

EXPERIMENTAL

Treatment with CASAD for 14 days

Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)

Interventions

Calcium Aluminosilicate Anti-Diarrheal (CASAD) DRUG

CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up

Also known as: CASAD

Open Label CASAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• C. difficile-associated diarrhea at the time of enrollment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salient Pharmaceuticals Incorporated: lead
• Scott and White Hospital & Clinic: collaborator
• Texas A&M University: collaborator

Study Sites (1)

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Diarrhea; Infections; Spasm

Interventions

Calcium Aluminosilicate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds

Limitations and Caveats

This study was terminated early for slow enrollment. Only 2 patients were enrolled during the open period. One of the two took less than 50% of the prescribed study drug. The results are not meaningful.

Results Point of Contact

• Title: Richard scruggs
• Organization: Salient Pharmaceuticals Incorporated

rscruggs@salientpharmaceuticals.com

7135899859

Study Officials

• Aarthi Narasimhan, MD

  Scott & White Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2012
• First Posted: April 4, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

US (1)