Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: CDI
In brief
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.
Key facts
- Study ID
- NCT04241744
- Run by
- Creighton University
- People needed
- 0
- Starts
- 2019-10-29
- Expected to finish
- 2020-01-13
- Last updated by the study team
- 2020-01-27
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months
- Patients diagnosed with gastrointestinal infection other than CDI
- Patients who have received a solid-organ transplant in the past 12 months
- Females who are pregnant or immediately post-partum
- Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of < 200 cell/mm3
- Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples
- Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)
Where it is running
- Creighton University Medical Center - Bergan Mercy — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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