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

Creighton University

Status and phase: Withdrawn; Phase 4

Conditions: CDI

Treatments: Drug: Vancomycin 125 MG po BID

Study type: Interventional

Funder types: Other

Identifiers

NCT04241744

2000200-01

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

vancomycin oral solution

Active Comparator group

Description:

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.

Treatment:

Drug: Vancomycin 125 MG po BID

placebo oral solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vancomycin 125 MG po BID