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Treatment of Initial Clostridium Difficile Infection

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FMT
Vancomycin
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of CDI (first episode)
  • Older than 18 years old

Exclusion Criteria:

  • Patients younger than 18 years old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Vancomycin

    FMT-FURM

    Arm Description

    Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days

    Patients in this arm receive FMT-FURM

    Outcomes

    Primary Outcome Measures

    Decrease in number of evacuations
    The cure of CDI was measured

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    April 15, 2017
    Sponsor
    Universidad Autonoma de Nuevo Leon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03107169
    Brief Title
    Treatment of Initial Clostridium Difficile Infection
    Official Title
    Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    September 30, 2015 (Actual)
    Study Completion Date
    September 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de Nuevo Leon

    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
    Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.
    Detailed Description
    Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Patients were randomized by a closed envelope method in a 1: 1 ratio to either oral vancomycin (every 6 h for 10-14 days) or a FMT-FURM
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancomycin
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days
    Arm Title
    FMT-FURM
    Arm Type
    Experimental
    Arm Description
    Patients in this arm receive FMT-FURM
    Intervention Type
    Other
    Intervention Name(s)
    FMT
    Other Intervention Name(s)
    fecal microbiota transplant
    Intervention Description
    Patients in the FMT group received FMT-FURM
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Other Intervention Name(s)
    Glycopeptide
    Intervention Description
    Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)
    Primary Outcome Measure Information:
    Title
    Decrease in number of evacuations
    Description
    The cure of CDI was measured
    Time Frame
    up to a 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of CDI (first episode) Older than 18 years old Exclusion Criteria: Patients younger than 18 years old

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Initial Clostridium Difficile Infection

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