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临床试验/NCT03592082
NCT03592082撤回4 期

Can Use of Bismuth Subsalicylate in Clostridium Difficile Patients Decrease the Length of Stay and Time to Resolution of Symptoms

Bassett Healthcare1 个研究点 分布在 1 个国家开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Length of stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

none - open label study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Standard care alone

Active Comparator

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

干预措施: standard antibiotic therapy (Drug)

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.

干预措施: Bismuth Subsalicylate (Drug)

结局指标

主要结局

Length of stay

时间窗: 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

次要结局

  • CDiff Recurrence(70 days)
  • Time to resolution of symptoms(70 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Victory, RN, CCRC

Clinical Research Nurse Supervisor

Bassett Healthcare

研究点 (1)

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