Clostridium Difficile InfectionPhase 4NCT03592082
Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
A Phase 4 study testing Bismuth Subsalicylate and standard antibiotic therapy in people with Clostridium Difficile Infection, run by Bassett Healthcare at 1 site in United States.
Trial summary
Clostridium difficle infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging tasks for clinicians due to treatment resistance developed from new hypervirulent strains. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Bismuth Subsalicylate and standard antibiotic therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Age 18 or older
- Hospitalized patient with documented positive stool test for CDiff
- Able and willing to provide informed consent
Who cannot join
- Pregnancy
- Breastfeeding
- Known allergy to BSS or other salicylates, including aspirin
- History of bleeding disorder
- History of gastrointestinal bleed,
- History of gastrointestinal ulcer
- Chronic use of anticoagulants
- Chronic NSAID use
Trial locations and contacts
1 site in 1 country.
United States1 site
Bassett Healthcare Network
Cooperstown, New York, 13326
About this study
Official title: Can Use of Bismuth Subsalicylate in Clostridium Difficile Patients Decrease the Length of Stay and Time to Resolution of Symptoms
Clostridium difficle infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging tasks for clinicians due to treatment resistance developed from new hypervirulent strains. The recurrence rate of this infection is around 20% and there is high likelihood(60-70%) of another episode after index recurrence. Given constant challenge new treatment options are under study. Aim of the study is to evaluate if use of bismuth subsalicylate (BSS) can decrease the length of stay in patients admitted with Clostridium difficile infection. Secondarily investigators will also see if there is any impact of BSS in decrease the recurrence.
Read the detailed description
Clostridium difficile (C.Diff) infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging task for clinicians due to treatment resistance developed from new hypervirulent strains. The recurrence rate of this infection is around 20% and there is high likelihood (60-70%) of another episode after index recurrence. Given constant challenges new treatment options are under study.
The purpose of this study is to examine if the addition of bismuth subsalicylate (BSS) (the active ingredient in Pepto-Bismol) 524 mg ((2) 262 mg tablets) given four times per day for 14 days to standard of care treatment of C.Diff will decrease the length of stay and decrease the time to resolution of C.Diff symptoms compared to patients who received standard of care treatment for C.Diff alone.
Bismuth subsalicylate has been used for long time in infectious diarrhea and is over the counter drug with few side effects. Studies in hamsters have shown bismuth subsalicylate to be effective in treating C.Diff. Investigators believe given cheaper cost and less side effect profile this drug is worth looking for treatment of C.Diff infection which has a huge burden on health care.
This is an open label, randomized, controlled trial. Hospitalized patients aged 18 years or older with positive stool test for C.Diff toxin will be randomized to one of two treatment groups:
Group 1 will receive standard of care treatment for C.Diff alone Group 2 will receive BSS 524 mg four times daily for 14 days along with standard of care treatment Oral antibiotic therapy will be limited to oral vancomycin 125 mg every 6 hours daily which is the standard dose for the treatment of clostridium difficile.
Length of stay and time to resolution of symptoms will be measured and compared between the two treatment groups as primary outcomes. Resolution of symptoms is defined has having < 3 diarrheal episodes in 24 hours. The study will also record episodes of recurrence, defined as the reappearance of symptoms within 8 weeks of the completion of antibiotic treatment and the resolution of initial symptoms. Recurrence rates will be compared between the two treatment groups as a secondary outcome.
Both Groups 1 \& 2 will have 2 week and 8 week follow up phone calls. Group 1 participants will be called 2 weeks after consent/enrollment in the study to verify antibiotic therapy is completed, verify when/if CDiff symptoms resolved, collect data about any adverse events. Group 2 participants will be called 2 weeks after the initiation of study drug (which should be < 24 hours after consent). The visit window will start on the day the participant is scheduled to complete study drug. The purpose of the call will be to verify that both antibiotics and study drug have been completed, verify when/if CDiff symptoms resolved, and collect data about any adverse events.
Both Groups 1 and 2 participants will be called 8 weeks after the expected (or known) completion date of antibiotic therapy prescribed for the treatment of CDiff to see if CDiff symptoms have recurred and if there have been any adverse events..
- Conditions
- Clostridium Difficile Infection
- Being tested
- Bismuth Subsalicylate, standard antibiotic therapy
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth SubsalicylateDrug
BSS 524 mg ((2) 262 mg tablets) given four times per day for 14 days
standard antibiotic therapyDrug
antibiotic therapy administered per standard protocol
| Study group | Role | What they receive |
|---|---|---|
| Standard care alone | Active comparator | Participants will receive standard antibiotic therapy for Clostridium Difficile (CDiff) infection without additional adjuvant therapy. Receives: Drug: standard antibiotic therapy |
| Standard care with Bismuth subsalicylate (BSS) | Experimental | Participants will receive BSS524 mg ((2) 262 mg tablets) four times per day for 14 days in addition to standard antibiotic therapy. Receives: Drug: Bismuth Subsalicylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
number of days hospitalized after the initiation of treatment for CDiff
Measured: 70 days (study period = 14 days of antibiotic treatment plus 8 weeks/56 days post treament completion)
Secondary outcomes (2)
Time to resolution of symptoms
Resolution of symptoms is defined as having < 3 diarrheal episodes in 24 hours
Measured: 70 days
CDiff Recurrence
Recurrence is defined as the reappearance of symptoms within 8 weeks of the completion of antibiotic treatment and the resolution of initial symptoms
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Victory, RN, CCRC, Bassett Healthcare
- Investigators
- Abdulhadi Quadri, MD, Principal investigator, Bassett Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592082
- Sponsor's protocol ID
- 2089
- Status last verified
- Jul 2018
- First submitted
- 17 Jan 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Use of Bismuth Subsalicylate in Clostridium Difficile Patients Decrease the Length of Stay and Time to Resolution of Symptoms
- ClinicalTrials.gov ID
- NCT03592082
- Acronym / sponsor ID
- 2089
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clostridium difficle infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging tasks for clinicians due to treatment resistance developed from new hypervirulent strains. The recurrence rate of this infection is around 20% and there is high likelihood(60-70%) of another episode after index recurrence. Given constant challenge new treatment options are under study. Aim of the study is to evaluate if use of bismuth subsalicylate (BSS) can decrease the length of stay in patients admitted with Clostridium difficile infection. Secondarily investigators will also see if there is any impact of BSS in decrease the recurrence.
Detailed description
Clostridium difficile (C.Diff) infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging task for clinicians due to treatment resistance developed from new hypervirulent strains. The recurrence rate of this infection is around 20% and there is high likelihood (60-70%) of another episode after index recurrence. Given constant challenges new treatment options are under study.
The purpose of this study is to examine if the addition of bismuth subsalicylate (BSS) (the active ingredient in Pepto-Bismol) 524 mg ((2) 262 mg tablets) given four times per day for 14 days to standard of care treatment of C.Diff will decrease the length of stay and decrease the time to resolution of C.Diff symptoms compared to patients who received standard of care treatment for C.Diff alone.
Bismuth subsalicylate has been used for long time in infectious diarrhea and is over the counter drug with few side effects. Studies in hamsters have shown bismuth subsalicylate to be effective in treating C.Diff. Investigators believe given cheaper cost and less side effect profile this drug is worth looking for treatment of C.Diff infection which has a huge burden on health care.
This is an open label, randomized, controlled trial. Hospitalized patients aged 18 years or older with positive stool test for C.Diff toxin will be randomized to one of two treatment groups:
Group 1 will receive standard of care treatment for C.Diff alone Group 2 will receive BSS 524 mg four times daily for 14 days along with standard of care treatment Oral antibiotic therapy will be limited to oral vancomycin 125 mg every 6 hours daily which is the standard dose for the treatment of clostridium difficile.
Length of stay and time to resolution of symptoms will be measured and compared between the two treatment groups as primary outcomes. Resolution of symptoms is defined has having < 3 diarrheal episodes in 24 hours. The study will also record episodes of recurrence, defined as the reappearance of symptoms within 8 weeks of the completion of antibiotic treatment and the resolution of initial symptoms. Recurrence rates will be compared between the two treatment groups as a secondary outcome.
Both Groups 1 \& 2 will have 2 week and 8 week follow up phone calls. Group 1 participants will be called 2 weeks after consent/enrollment in the study to verify antibiotic therapy is completed, verify when/if CDiff symptoms resolved, collect data about any adverse events. Group 2 participants will be called 2 weeks after the initiation of study drug (which should be < 24 hours after consent). The visit window will start on the day the participant is scheduled to complete study drug. The purpose of the call will be to verify that both antibiotics and study drug have been completed, verify when/if CDiff symptoms resolved, and collect data about any adverse events.
Both Groups 1 and 2 participants will be called 8 weeks after the expected (or known) completion date of antibiotic therapy prescribed for the treatment of CDiff to see if CDiff symptoms have recurred and if there have been any adverse events..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care alone | Active comparator | Drug: standard antibiotic therapyParticipants will receive standard antibiotic therapy for Clostridium Difficile (CDiff) infection without additional adjuvant therapy. |
| Standard care with Bismuth subsalicylate (BSS) | Experimental | Drug: Bismuth SubsalicylateParticipants will receive BSS524 mg ((2) 262 mg tablets) four times per day for 14 days in addition to standard antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Hospitalized patient with documented positive stool test for CDiff
- Able and willing to provide informed consent
Key exclusion criteria (8 listed)
- Pregnancy
- Breastfeeding
- Known allergy to BSS or other salicylates, including aspirin
- History of bleeding disorder
- History of gastrointestinal bleed,
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 |
|---|---|---|
| Bismuth SubsalicylateBSS 524 mg ((2) 262 mg tablets) given four times per day for 14 days | Drug | Standard care with Bismuth subsalicylate (BSS) |
| standard antibiotic therapyantibiotic therapy administered per standard protocol | Drug | Standard care alone |
Primary outcome
Length of stay
Time frame: 70 days (study period = 14 days of antibiotic treatment plus 8 weeks/56 days post treament completion)
number of days hospitalized after the initiation of treatment for CDiff
2 secondary outcomes
Time to resolution of symptoms
Time frame: 70 days
CDiff Recurrence
Time frame: 70 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile Infection
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
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Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
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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.
Abdulhadi Quadri, MD principal investigator
Bassett Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bismuth Subsalicylate and standard antibiotic therapy in people with Clostridium Difficile Infection, run by Bassett Healthcare 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Jul 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Length of stay (time frame: 70 days (study period = 14 days of antibiotic treatment plus 8 weeks/56 days post treament completion)). 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 19 Jul 2018.