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NCT Number: NCT02996487

Screening to Prophylax Against Clostridium Difficile Infection -

The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

William Beaumont Hospital, Dearborn, Michigan, United States

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About this study

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 polymerase chain reaction (PCR) test. 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 by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.

Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Placebo

Other

Primary outcomes

  1. The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.

    Time frame: 12 weeks after treatment

    Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (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 enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.

Secondary outcomes

  1. The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.

    Time frame: 12 weeks after treatment

    Number of randomized participants with mild, moderate, severe or fulminant disease after treatment. This outcome is only applicable to the two randomized arms.

  2. The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.

    Time frame: 12 weeks after treatment

    Number of participants who developed C difficile infection after treatment. This outcome is only applicable to the two randomized arms.

  3. The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.

    Time frame: 12 weeks after treatment

    Number of participants who remained colonized with C. difficile after treatment. This outcome is only applicable to the two randomized arms.

  4. The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.

    Time frame: 12 weeks after antibiotics

    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.

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

Screening to Prophylax Against Clostridium Difficile Infection

Acronym: StoP CDI

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2016
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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