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Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (VANCALLO)

Primary Purpose

Clostridium Difficile Infections, Stem Cell Transplant Complications

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infections

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥15 ans
  • Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning
  • For men and women of reproductive age: use of contraceptives
  • Informed consent
  • Healthcare insurance

Exclusion Criteria:

  • Know allergy or history of adverse events with vancomycine
  • Pregnancy
  • Clostridium difficile infection within 30 days prior to inclusion or at inclusion
  • History of total colectomy and/or inflammatory bowel disease
  • Progressive diarrhea at inclusion, whichever the etiology
  • Digestive decontamination protocol for the stem cell transplant procedure
  • Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vancomycine

    Placebo

    Arm Description

    Oral vancomycine 125 mg twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.

    Vancomycine placebo, twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.

    Outcomes

    Primary Outcome Measures

    Proportion of patients with Clostridium difficile infection
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).

    Secondary Outcome Measures

    Proportion of patients with Clostridium difficile infection
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Cumulative incidence of Clostridium difficile infection
    Time between inclusion and Clostridium difficile infection, occurring before hospital discharge or the end of study treatment (that is 5 weeks from inclusion if the patient is still hospitalized), defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Proportion of patients with Clostridium difficile infection by PCR testing
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive toxinogenic Clostridium difficile PCR (polymerase chain reaction) testing, without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Factors associated with the proportion of patients with Clostridium difficile infection
    Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition
    Proportion of patients with severe Clostridium difficile infection
    Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count>20000/mm3, general deterioration
    Proportion of patients with bacterial infection
    Bacterial infection defined as occurrence of a bacterial infection (any site)
    Proportion of patients with vancomycin-resistant enterococcus carriage
    Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab
    Gut microbiome profile
    Evolution of gut microbiome profile during the study
    Nosocomial Clostridium difficile infection clusters
    Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks
    Proportion of patients with Graft-versus-Host disease
    Graft-versus-Host disease, acute or chronic, grade 2 to 4
    Cumulative incidence of relapse
    Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months
    Treatment-related mortality
    Proportion of death related to allogeneic stem cell transplant procedures
    Overall survival
    Time between inclusion and death or last follow-up, up to a maximum of 12 months

    Full Information

    First Posted
    January 28, 2022
    Last Updated
    February 17, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    GIRCI Ile de France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05256693
    Brief Title
    Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
    Acronym
    VANCALLO
    Official Title
    Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant: a Double-blind Placebo-controlled Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    GIRCI Ile de France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Clostridium difficile (CD) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The VANCALLO trial aims at evaluating oral vancomycine reducing the risk of CD infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Infections, Stem Cell Transplant Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    336 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancomycine
    Arm Type
    Experimental
    Arm Description
    Oral vancomycine 125 mg twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Vancomycine placebo, twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Intervention Description
    Oral vancomycin (powder) 125mg twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Vancomycine placebo (powder) twice a day
    Primary Outcome Measure Information:
    Title
    Proportion of patients with Clostridium difficile infection
    Description
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with Clostridium difficile infection
    Description
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Time Frame
    12 weeks
    Title
    Cumulative incidence of Clostridium difficile infection
    Description
    Time between inclusion and Clostridium difficile infection, occurring before hospital discharge or the end of study treatment (that is 5 weeks from inclusion if the patient is still hospitalized), defined as a diarrhea (> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Time Frame
    5 weeks
    Title
    Proportion of patients with Clostridium difficile infection by PCR testing
    Description
    Clostridium difficile infection defined as a diarrhea (> 3 loose stools/day) with positive toxinogenic Clostridium difficile PCR (polymerase chain reaction) testing, without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy).
    Time Frame
    5 weeks
    Title
    Factors associated with the proportion of patients with Clostridium difficile infection
    Description
    Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition
    Time Frame
    5 weeks
    Title
    Proportion of patients with severe Clostridium difficile infection
    Description
    Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count>20000/mm3, general deterioration
    Time Frame
    5 weeks
    Title
    Proportion of patients with bacterial infection
    Description
    Bacterial infection defined as occurrence of a bacterial infection (any site)
    Time Frame
    5 weeks
    Title
    Proportion of patients with vancomycin-resistant enterococcus carriage
    Description
    Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab
    Time Frame
    5 weeks
    Title
    Gut microbiome profile
    Description
    Evolution of gut microbiome profile during the study
    Time Frame
    12 weeks
    Title
    Nosocomial Clostridium difficile infection clusters
    Description
    Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks
    Time Frame
    12 weeks
    Title
    Proportion of patients with Graft-versus-Host disease
    Description
    Graft-versus-Host disease, acute or chronic, grade 2 to 4
    Time Frame
    12 months
    Title
    Cumulative incidence of relapse
    Description
    Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months
    Time Frame
    12 months
    Title
    Treatment-related mortality
    Description
    Proportion of death related to allogeneic stem cell transplant procedures
    Time Frame
    5 weeks
    Title
    Overall survival
    Description
    Time between inclusion and death or last follow-up, up to a maximum of 12 months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥15 ans Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning For men and women of reproductive age: use of contraceptives Informed consent Healthcare insurance Exclusion Criteria: Know allergy or history of adverse events with vancomycine Pregnancy Clostridium difficile infection within 30 days prior to inclusion or at inclusion History of total colectomy and/or inflammatory bowel disease Progressive diarrhea at inclusion, whichever the etiology Digestive decontamination protocol for the stem cell transplant procedure Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inès Boussen, MD
    Phone
    +33 1 42 49 90 66
    Email
    ines.boussen@aphp.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

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