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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

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Oral Vancomycin Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Study placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 30-day hospital re-admission [ Time Frame: 30 days ]
    All-cause re-admission to any hospital

  3. 30-day mortality [ Time Frame: 30 days ]
    All-cause mortality in the 30 days following completion of the systemic antibiotics


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Vancomycin resistance isolated [ Time Frame: 90 days ]
    Isolation of a vancomycin-resistant bacteria during an infectious workup, if clinically indicated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200093


Locations
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United States, New York
Rochester General Hospital
Rochester, New York, United States, 14621
Sponsors and Collaborators
Rochester General Hospital
Investigators
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Principal Investigator: Maryrose R Laguio-Vila, MD Rochester General Hospital

Publications:

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Responsible Party: Maryrose R Laguio-Vila, Physician, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT03200093     History of Changes
Other Study ID Numbers: CIC 1745-B-17 Laguio-Vila
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Maryrose R Laguio-Vila, Rochester General Hospital:
Clostridium difficile
C diff
Oral Vancomycin
Prophylaxis
Additional relevant MeSH terms:
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Clostridium Infections
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents