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Screening to Prophylax Against Clostridium Difficile Infection - (StoP CDI)

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Expected duration of admission sufficient to complete screening and enrollment
  2. Age ≥18
  3. Able to give informed consent
  4. Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
  5. Maximum expected duration of antibiotics 8 weeks
  6. Able to take oral study medications
  7. Able to provide a stool sample during hospitalization or within 3 days of discharge
  8. Reasonably expected to be able to complete follow up

Exclusion Criteria:

  1. Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
  2. CDI within prior 90 days
  3. Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
  4. Current diarrhea
  5. Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
  6. Pregnancy or breast feeding (determined prior to randomization)
  7. Travel to an area of endemic diarrheal illness within the last 30 days
  8. Life expectancy of less than 60 days
  9. Known allergy to vancomycin
  10. Participation with other research trials that could impact the results of this trial within the last 30 days
  11. Previously enrolled in this study

Sites / Locations

  • William Beaumont Hospital
  • William Beaumont Hospital
  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

vancomycin

Arm Description

Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.

Vancomycin 125 mg by mouth every 6 hours

Outcomes

Primary Outcome Measures

The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile.
Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, PCR testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin EIA, and clinical symptoms compatible with CDI.

Secondary Outcome Measures

The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo.
Number of participants with mild, moderate, severe or fulminant disease after treatment
The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo.
Number of participants who developed C difficile infection after treatment.
The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR.
Number of participants who remained colonized with C. difficile after treatment
The incidence of CDI in patients initiated on high risk antibiotics who are not colonized with toxigenic C. difficile.
Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.

Full Information

First Posted
November 17, 2016
Last Updated
August 9, 2023
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02996487
Brief Title
Screening to Prophylax Against Clostridium Difficile Infection -
Acronym
StoP CDI
Official Title
Screening to Prophylax Against Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. diff who are admitted to the hospital and need antibiotics for another infection.
Detailed Description
Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200. Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by PCR. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms: Arm 1: Patients receive 125 mg vancomycin PO q6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days. Arm 2: Patients receive placebo PO q6 hours for the duration of their antibiotic treatment +3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.
Arm Title
vancomycin
Arm Type
Active Comparator
Arm Description
Vancomycin 125 mg by mouth every 6 hours
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile.
Description
Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, PCR testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin EIA, and clinical symptoms compatible with CDI.
Time Frame
12 weeks after treatment
Secondary Outcome Measure Information:
Title
The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo.
Description
Number of participants with mild, moderate, severe or fulminant disease after treatment
Time Frame
12 weeks after treatment
Title
The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo.
Description
Number of participants who developed C difficile infection after treatment.
Time Frame
12 weeks after treatment
Title
The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR.
Description
Number of participants who remained colonized with C. difficile after treatment
Time Frame
12 weeks after treatment
Title
The incidence of CDI in patients initiated on high risk antibiotics who are not colonized with toxigenic C. difficile.
Description
Number of participants who developed CDI in this subgroup of patients as assessed by clinical presentation and PCR testing of stool. Patients are considered to have CDI if they have a positive PCR test and clinical symptoms compatible with CDI.
Time Frame
12 weeks after antibiotics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Expected duration of admission sufficient to complete screening and enrollment Age ≥18 Able to give informed consent Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin Maximum expected duration of antibiotics 8 weeks Able to take oral study medications Able to provide a stool sample during hospitalization or within 3 days of discharge Reasonably expected to be able to complete follow up Exclusion Criteria: Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness CDI within prior 90 days Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile Current diarrhea Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut Pregnancy or breast feeding (determined prior to randomization) Travel to an area of endemic diarrheal illness within the last 30 days Life expectancy of less than 60 days Known allergy to vancomycin Participation with other research trials that could impact the results of this trial within the last 30 days Previously enrolled in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Sims, MD PhD
Organizational Affiliation
Beaumont Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Screening to Prophylax Against Clostridium Difficile Infection -

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