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Use of Bismuth Subsalicylate in Clostridium Difficile Colitis

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ClinicalTrials.gov Identifier: NCT03592082
Recruitment Status : Withdrawn (Investigator left institution)
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Victory, RN, CCRC, Bassett Healthcare

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Bismuth Subsalicylate Drug: standard antibiotic therapy Phase 4

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..


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: none - open label study
Primary Purpose: Treatment
Official Title: Can Use of Bismuth Subsalicylate in Clostridium Difficile Patients Decrease the Length of Stay and Time to Resolution of Symptoms
Estimated Study Start Date : March 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care alone
Participants will receive standard antibiotic therapy for Clostridium Difficile (CDiff) infection without additional adjuvant therapy.
Drug: standard antibiotic therapy
antibiotic therapy administered per standard protocol

Experimental: Standard care with Bismuth subsalicylate (BSS)
Participants will receive BSS524 mg ((2) 262 mg tablets) four times per day for 14 days in addition to standard antibiotic therapy.
Drug: Bismuth Subsalicylate
BSS 524 mg ((2) 262 mg tablets) given four times per day for 14 days




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to resolution of symptoms [ Time Frame: 70 days ]
    Resolution of symptoms is defined as having < 3 diarrheal episodes in 24 hours

  2. CDiff Recurrence [ Time Frame: 70 days ]
    Recurrence is defined as the reappearance of symptoms within 8 weeks of the completion of antibiotic treatment and the resolution of initial symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Hospitalized patient with documented positive stool test for CDiff
  • Able and willing to provide informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592082


Locations
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United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Sponsors and Collaborators
Bassett Healthcare
Investigators
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Principal Investigator: Abdulhadi Quadri, MD Bassett Medical Center

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Responsible Party: Jennifer Victory, RN, CCRC, Clinical Research Nurse Supervisor, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT03592082     History of Changes
Other Study ID Numbers: 2089
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Bismuth
Bismuth subsalicylate
Anti-Infective Agents
Antitubercular Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antidiarrheals