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

NCT ID: NCT04241744

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2020-01-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

vancomycin oral solution

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.

Group Type: ACTIVE_COMPARATOR

Vancomycin 125 MG po BID

Intervention Type: DRUG

prevention to develop CDI during hospitalization

placebo oral solution

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.

Group Type: PLACEBO_COMPARATOR

Vancomycin 125 MG po BID

Intervention Type: DRUG

prevention to develop CDI during hospitalization

Interventions

Vancomycin 125 MG po BID

prevention to develop CDI during hospitalization

Intervention Type: DRUG

Other Intervention Names

placebo oral solution po BID

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Destache

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

2000200-01

Identifier Type: -

Identifier Source: org_study_id