Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2021-04-22

Brief Summary

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This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. Half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

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Detailed Description

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Clostridium difficile colitis is a significant cause of morbidity and mortality among hospitalized patients. Following the first episode, up to 15% of people experience recurrent disease. A major risk factor for recurrent disease is exposure to systemic antibiotics.

Oral vancomycin given four times daily is one of the treatments for Clostridium difficile infection; it is not known if giving oral vancomycin at a lower dose such as once daily may help prevent recurrences. Oral vancomycin may be most helpful in preventing recurrences when given to patients at greatest risk of recurrent disease, such as when they are receiving systemic antibiotics.

To evaluate this, the investigators propose comparing the rates of recurrent Clostridium difficile infection in patients who receive oral vancomycin with systemic antibiotics to when patients take systemic antibiotics alone.

Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

After enrollment, study pharmacists will randomize the participants to receive either oral vancomycin or placebo. Participants, care providers, investigators, and outcomes assessors will be masked.

Study Groups

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Oral vancomycin

Oral vancomycin solution 125 mg in 2.5 mL, combined with 2.5 ml Ora-Sweet solution, to total 5 mL.

Taken by mouth once daily for:

1. If the total duration of systemic antibiotics is less than or equal to 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus three days.
2. If the total duration of systemic antibiotics is greater than 14 days, oral vancomycin will be taken for the duration of the systemic antibiotics plus seven days.

Group Type EXPERIMENTAL

Oral Vancomycin

Intervention Type DRUG

Oral vancomycin solution 125 mg in 2.5 mL combined with 2.5 mL Ora-Sweet. A total of 5 mL combined solution taken by mouth once daily.

Placebo arm

Ora-Sweet 5 mL

Taken by mouth once daily for:

1. If the total duration of systemic antibiotics is less than or equal to 14 days, placebo will be taken for the duration of the systemic antibiotics plus three days.
2. If the total duration of systemic antibiotics is greater than 14 days, placebo will be taken for the duration of the systemic antibiotics plus seven days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ora-Sweet 5mL taken by mouth once daily.

Interventions

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Oral Vancomycin

Oral vancomycin solution 125 mg in 2.5 mL combined with 2.5 mL Ora-Sweet. A total of 5 mL combined solution taken by mouth once daily.

Intervention Type DRUG

Placebo

Ora-Sweet 5mL taken by mouth once daily.

Intervention Type DRUG

Other Intervention Names

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Study drug Study placebo

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and older
* Any history of Clostridium difficile infection based on a positive Clostridium difficile stool test performed at a lab affiliated with Rochester Regional Health System or patient report
* A new in-patient admission, with an antibiotic treatment plan for greater than 48 hours

Exclusion Criteria

* Documented allergy and/or adverse drug reaction to vancomycin
* Pregnant
* Patients who are admitted with a current episode of Clostridium difficile infection
* Patients with total colectomy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No