Oral Vancomycin for Preventing Clostridium Difficile Recurrence

April 22, 2021 updated by: Maryrose R Laguio-Vila, Rochester General Hospital

Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Study drug
Placebo Comparator: 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.
Drug: Placebo
Ora-Sweet 5mL taken by mouth once daily.
Other Names:
  • Study placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day recurrent Clostridium difficile infection
Time Frame: 30 days
A positive Clostridium difficile stool test in the 30 days following completion of the systemic antibiotic treatment.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day recurrent Clostridium difficile infection
Time Frame: 90 days
A positive Clostridium difficile stool test in the 90 days following completion of the systemic antibiotic treatment.
90 days
30-day hospital re-admission
Time Frame: 30 days
All-cause re-admission to any hospital
30 days
30-day mortality
Time Frame: 30 days
All-cause mortality in the 30 days following completion of the systemic antibiotics
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of duration of systemic antibiotics on Clostridium difficile recurrence
Time Frame: 90 days
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the duration of systemic antibiotics was less than or equal to 14 days compared to longer durations.
90 days
Impact of acid-suppressing medications on Clostridium difficile recurrence
Time Frame: 90 days
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving acid-suppressing medications compared to those on none.
90 days
Impact of age on Clostridium difficile recurrence
Time Frame: 90 days
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was older than 65 years of age compared to younger.
90 days
Impact of systemic antibiotic class on Clostridium difficile recurrence
Time Frame: 90 days
Comparing the frequency of a positive Clostridium difficile stool test in the 90 days following completion of systemic antibiotics, when the participant was receiving systemic antibiotics considered "high risk" for Clostridium difficile compared to those taking "low risk" antibiotics.
90 days
Vancomycin resistance isolated
Time Frame: 90 days
Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Investigators

  • Principal Investigator: Maryrose R Laguio-Vila, MD, Rochester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

April 22, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC 1745-B-17 Laguio-Vila

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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