Oral Vancomycin vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection (PREVAN)
Primary Purpose
Clostridioides Difficile Infection
Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Oral Vancomycin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Clostridioides Difficile Infection focused on measuring Vancomycin oral capsules
Eligibility Criteria
Inclusion Criteria:
- Age equal or superior to 18 years
- Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
- Need for hospitalization and need of antibiotic therapy
- Signature of informed consent
Exclusion Criteria:
- Woman of childbearing age, pregnant woman, or breastfeeding woman
- Patients allergic to vancomycin
- Impossibility of fulfilling the study protocol
- Critically ill condition or life expectancy less than 30 days
- Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
- Patients that meet diarrhea criteria or that present a Clostridioides Difficile infection at the time of patient's recruitment or during the 3 days prior.
- Antibiotic therapy with oral vancomycin at the time of patient's selection or during the 3 days prior, or with any drug that is effective against Clostrioides Difficile.
- Antibiotic prophylaxis with oral vancomycin or with any drug that is effective against Clostrioides difficile during the 90 days before the recruitment.
- Systemic antibiotic therapy for 72 hours or more before the recruitment
- Enrolment in another clinical trial that evaluates other drugs' effectiveness
- Estimated use of systemic antibiotic therapy for more than 4 weeks
Sites / Locations
- Rafael San JuanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Placebo group
Arm Description
A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.
A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
Outcomes
Primary Outcome Measures
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
Secondary Outcome Measures
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence)
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo
Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed.
Tolerance and safety of treatment with oral vancomycin
Rate of major adverse events and drug-related adverse events.
Full Information
NCT ID
NCT05320068
First Posted
March 22, 2022
Last Updated
April 20, 2023
Sponsor
Julia Orígüen
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT05320068
Brief Title
Oral Vancomycin vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
Acronym
PREVAN
Official Title
Phase III,Randomized,Double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.Difficile Infection in Patients Under Treatment With Systemic Antibiotic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julia Orígüen
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
Detailed Description
As secondary objectives the investigators intend to:
Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences.
Compare the severity of recurrences in both study groups.
Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed.
Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance.
Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
Keywords
Vancomycin oral capsules
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Proportion 2:1 in favour to the intervention arm
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
Intervention Type
Drug
Intervention Name(s)
Oral Vancomycin
Intervention Description
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
Primary Outcome Measure Information:
Title
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Description
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
Time Frame
60 days after the beginning of the intervention
Secondary Outcome Measure Information:
Title
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
Description
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence)
Time Frame
60 days after the beginning of the intervention
Title
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
Description
The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo
Time Frame
60 days after the beginning of the intervention
Title
Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
Description
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed.
Time Frame
60 days after the beginning of the intervention
Title
Tolerance and safety of treatment with oral vancomycin
Description
Rate of major adverse events and drug-related adverse events.
Time Frame
60 days after the beginning of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age equal or superior to 18 years
Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
Need for hospitalization and need of antibiotic therapy
Signature of informed consent
Exclusion Criteria:
Woman of childbearing age, pregnant woman, or breastfeeding woman
Hypersensitivity to vancomycin
Inability to comply with study protocol
Critically ill condition or life expectancy less than 30 days
Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days
Therapy with oral vancomycin or any other agent with activity against C. difficile for >48 hours in the previous 3 days;.
Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility
Systemic antibiotic therapy for 72 hours or more before the recruitment
Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
Estimated use of systemic antibiotic therapy for more than 4 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAFAEL SAN-JUAN, M.D
Phone
0034609488076
Email
rafael.san@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAFAEL SAN-JUAN
Organizational Affiliation
HOSPITAL 12 DE OCTUBRE
Official's Role
Study Chair
Facility Information:
Facility Name
Rafael San Juan
City
Madrid
ZIP/Postal Code
28032
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAFAEL SAN-JUAN, MD.PhD.
Phone
609488076
Ext
4843
Email
rafasjg@yahoo.es
First Name & Middle Initial & Last Name & Degree
José María Aguado, MD. PhD.
Phone
0034913908000
Ext
4632
Email
jaguadog1@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication will be shared
IPD Sharing Time Frame
Data generated by the research will be made available as soon as possible, wherever legally and ethically possible. It is Planned to share data starting 9 months after publication, and data will be available for 24 months thereafter.
IPD Sharing Access Criteria
IPD will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to rafael.san@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.
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Oral Vancomycin vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
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