Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI

Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04241744

Enrollment

Registered

2020-01-27

Start date

2019-10-29

Completion date

2020-01-13

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CDI

Brief summary

The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI). Oral vancomycin is an antibiotic that is commonly used to treat CDI. The investigators want to study if using this drug can prevent the development of CDI while you are in the hospital receiving IV antibiotics. The key risk factors for developing CDI are age and IV antibiotic therapy. CDI is an infection in your colon caused by an organism called Clostridium difficile (or C. diff for short) that causes diarrhea. Up to 12% of hospital-acquired infections have been reported to be CDI. It can lead to longer hospital stays and more costs associated with the hospital stay.

Interventions

DRUGVancomycin 125 MG po BID

prevention to develop CDI during hospitalization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Masking description

placebo controlled

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* 1\. Older patients (\> 65 years of age), hospitalized for \> 48 hours and treated with parenteral antimicrobial therapy for \> 48 hours at CHI Creighton University Medical Center-Bergan Mercy will be eligible for enrollment.

Exclusion criteria

1. Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months 2. Patients diagnosed with gastrointestinal infection other than CDI 3. Patients who have received a solid-organ transplant in the past 12 months 4. Females who are pregnant or immediately post-partum 5. Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of \< 200 cell/mm3 6. Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples 7. Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)

Design outcomes

Primary

Measure	Time frame	Description
number of enrolled patients who develop CDI during hospitalization assessed (up to 3 month)	during hospitalization through study completion, assessed up to 3 months	number of enrolled patient with CDI receiving oral vancomycin compared to placebo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026