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

NCT04241744 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2000200-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

CDI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

vancomycin oral solution

ACTIVE COMPARATOR

vancomycin oral solution will be administered to consented patients \>65 years of age receiving IV antimicrobial(s) for a bacterial infection twice daily while hospitalized.

Drug: Vancomycin 125 MG po BID

placebo oral solution

PLACEBO COMPARATOR

placebo oral solution will be administered to consented patients \>65 years of age receiving IV antimicrobial(s) for a bacterial infection twice daily while hospitalized.

Drug: Vancomycin 125 MG po BID

Interventions

Vancomycin 125 MG po BID DRUG

prevention to develop CDI during hospitalization

Also known as: placebo oral solution po BID

placebo oral solution; vancomycin oral solution

Eligibility Criteria

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

You may qualify if:

• \. 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)

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: placebo controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: October 29, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)