Use of Bismuth Subsalicylate in Clostridium Difficile Colitis

NCT03592082 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Length of stay

  number of days hospitalized after the initiation of treatment for CDiff

  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

  70 days

• CDiff Recurrence

  70 days

Study Arms (2)

Standard care alone

ACTIVE COMPARATOR

Participants will receive standard antibiotic therapy for Clostridium Difficile (CDiff) infection without additional adjuvant therapy.

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.

Drug: Bismuth Subsalicylate

Interventions

Bismuth Subsalicylate DRUG

BSS 524 mg ((2) 262 mg tablets) given four times per day for 14 days

Standard care with Bismuth subsalicylate (BSS)

standard antibiotic therapy DRUG

antibiotic therapy administered per standard protocol

Standard care alone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

bismuth subsalicylate

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Abdulhadi Quadri, MD

  Bassett Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: none - open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Nurse Supervisor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: July 19, 2018
• Study Start: March 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)