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

CDI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04241744
• Other study ID #: 2000200-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 29, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: January 2020
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• CDI

Intervention

Drug:
• Vancomycin 125 MG po BID
prevention to develop CDI during hospitalization

Locations

Country	Name	City	State
United States	Creighton University Medical Center - Bergan Mercy	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

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