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Oral Vancomycin for Preventing Clostridium Difficile Recurrence

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ClinicalTrials.gov Identifier: NCT03200093
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maryrose R Laguio-Vila, Rochester General Hospital

Tracking Information
First Submitted Date  ICMJE June 23, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE June 8, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03200093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • 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.
  • 30-day hospital re-admission [ Time Frame: 30 days ]
    All-cause re-admission to any hospital
  • 30-day mortality [ Time Frame: 30 days ]
    All-cause mortality in the 30 days following completion of the systemic antibiotics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • Vancomycin resistance isolated [ Time Frame: 90 days ]
    Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Oral Vancomycin for Preventing Clostridium Difficile Recurrence
Official Title  ICMJE Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • 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 Name: Study drug
  • Drug: Placebo
    Ora-Sweet 5mL taken by mouth once daily.
    Other Name: Study placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oral Vancomycin
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03200093
Other Study ID Numbers  ICMJE CIC 1745-B-17 Laguio-Vila
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maryrose R Laguio-Vila, Rochester General Hospital
Study Sponsor  ICMJE Rochester General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maryrose R Laguio-Vila, MD Rochester General Hospital
PRS Account Rochester General Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP