Clinical trial NCT02996487: Screening to Prophylax Against Clostridium Difficile Infection -
Official title: Screening to Prophylax Against Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 1294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
timeFrame: 12 weeks after treatment
measure: The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.
timeFrame: 12 weeks after treatment
measure: The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.
timeFrame: 12 weeks after treatment
measure: The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.
timeFrame: 12 weeks after antibiotics
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: Beaumont Health
name: Matthew Sims, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: