Screening to Prophylax Against Clostridium Difficile Infection -

NCT02996487 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2016-254
• Study Type: interventional
• Target: 1,294
• Locations: 1 country
• Sites: 3

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.

Conditions

Clostridium Difficile Infection

Outcome Measures

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.

  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.

  12 weeks after treatment

Secondary Outcomes (4)

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

  12 weeks after treatment

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

  12 weeks after treatment

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

  12 weeks after treatment

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

  12 weeks after antibiotics

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

vancomycin

ACTIVE COMPARATOR

Vancomycin 125 mg by mouth every 6 hours

Drug: Vancomycin

Interventions

Vancomycin DRUG

vancomycin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (3)

William Beaumont Hospital

Dearborn, Michigan, 48124, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Maureen Cooney
• Organization: Beaumont Hospitals

maureen.cooney@corewellhealth.org

248 551-0099

Study Officials

• Matthew Sims, MD PhD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 19, 2016
• Study Start: December 19, 2016
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)