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Use of Bismuth Subsalicylate in Clostridium Difficile Colitis

NCT03592082 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-07-19

No results posted yet for this study

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

Interventions

DRUG

Bismuth Subsalicylate

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

DRUG

standard antibiotic therapy

antibiotic therapy administered per standard protocol

Sponsors & Collaborators

  • Bassett Healthcare

    lead OTHER

Principal Investigators

  • Abdulhadi Quadri, MD · Bassett Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-07-01
Completion
2018-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03592082 on ClinicalTrials.gov