Diarrhoea, Clostridium DifficilePhase 2NCT01570634
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
A Phase 2 study testing Calcium Aluminosilicate Anti-Diarrheal (CASAD) in people with Diarrhoea, Clostridium Difficile, run by Salient Pharmaceuticals Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhoea, Clostridium Difficile
- What is being tested?
- Calcium Aluminosilicate Anti-Diarrheal (CASAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott & White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection
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
- Being tested
- Calcium Aluminosilicate Anti-Diarrheal (CASAD)
- Keywords
- Clostridium difficile, infection, diarrhea, cramping
- Medical subject headings
- Diarrhea, Infections, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Aluminosilicate Anti-Diarrheal (CASAD)Drug
Also called CASAD
CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
| Study group | Role | What they receive |
|---|---|---|
| Open Label CASAD | Experimental | Treatment with CASAD for 14 days Receives: Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 42 days
Secondary outcomes (4)
Stools Per Day
Compare the number of liquid stools per day during treatment period
Measured: 14 days
Resolution of Abdominal Pain
Compare time to resolution of abdominal pain
Measured: 14 days
Absence of Relapse
Compare sustained clinical response
Measured: 42 days
Side-effects and Complications
Compare side-effects and complications
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Study was stopped for slow enrollment - only 2 patients, no evaluable results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diarrhoea, Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salient Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scott and White Hospital & Clinic, Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Aarthi Narasimhan, MD, Principal investigator, Scott & White Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570634
- Sponsor's protocol ID
- SAL-2011-01PCL-01
- Status last verified
- Feb 2013
- First submitted
- 1 Apr 2012
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT01570634
- Acronym / sponsor ID
- SAL-2011-01PCL-01
- Conditions
- Diarrhoea, Clostridium Difficile
- Keywords
- Clostridium difficile, infection, diarrhea, cramping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped for slow enrollment - only 2 patients, no evaluable results
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Salient Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Scott and White Hospital & Clinic, Texas A&M University
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label CASAD | Experimental | Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)Treatment with CASAD for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Aluminosilicate Anti-Diarrheal (CASAD)Also: CASADCASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up | Drug | Open Label CASAD |
Primary outcome
Resolution of Diarrhea
Time frame: 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).
4 secondary outcomes
Stools Per Day
Time frame: 14 days
Resolution of Abdominal Pain
Time frame: 14 days
Absence of Relapse
Time frame: 42 days
Side-effects and Complications
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarthi Narasimhan, MD principal investigator
Scott & White Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium Aluminosilicate Anti-Diarrheal (CASAD) in people with Diarrhoea, Clostridium Difficile, run by Salient Pharmaceuticals Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Diarrhea (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.