Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

Status Recruiting

Clinical Trial Summary

We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.

Clinical Trial Description

To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.

This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:

1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).

2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).

Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.

A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.

You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status.

Other medical information from your records and charts may also be collected by us for purposes of review for this study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02237859
Study type	Interventional
Source	Spectrum Health Hospitals
Contact
Status	Recruiting
Phase	Phase 4
Start date	August 2014
Completion date	August 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.