Diarrhoea, Clostridium Difficile
Conditions
Keywords
Clostridium difficile, infection, diarrhea, cramping
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.
Interventions
DRUGCalcium Aluminosilicate Anti-Diarrheal (CASAD)
CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
Sponsors
Scott and White Hospital & Clinic
Texas A&M University
Salient Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Diarrhea | 42 days | To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stools Per Day | 14 days | Compare the number of liquid stools per day during treatment period |
| Resolution of Abdominal Pain | 14 days | Compare time to resolution of abdominal pain |
| Absence of Relapse | 42 days | Compare sustained clinical response |
| Side-effects and Complications | 42 days | Compare side-effects and complications |
Countries
United States
Participant flow
Recruitment details
Recruiting was managed by Scott & White
Participants by arm
| Arm | Count |
|---|---|
| Open Label CASAD Treatment with CASAD for 14 days | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Open Label CASAD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 66.8 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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).
Time frame: 42 days
Population: The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.
Secondary
Absence of Relapse
Compare sustained clinical response
Time frame: 42 days
Population: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Secondary
Resolution of Abdominal Pain
Compare time to resolution of abdominal pain
Time frame: 14 days
Population: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Secondary
Side-effects and Complications
Compare side-effects and complications
Time frame: 42 days
Population: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Secondary
Stools Per Day
Compare the number of liquid stools per day during treatment period
Time frame: 14 days
Population: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.