The Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT04637321
Collaborator
(none)
585
1
9.1
64.3

Study Details

Study Description

Brief Summary

2.1. Study Objectives

  • Primary Objective(s)

  • Identify the incidence and risk of CDI within one year after kidney, liver, and/or pancreas transplant

  • Secondary Objective(s)

  • Identify the risk factors for recurrent CDI post-transplant in patients who were diagnosed with a CDI within one year prior to Solid Organ Transplant

  • Evaluate the impact of CDI on graft survival following Solid Organ Transplant

Condition or Disease Intervention/Treatment Phase
  • Procedure: Solid organ transplant

Detailed Description

  • Single center, retrospective cohort chart review study design

  • Data will be collected on all liver, kidney, pancreas and combined transplant recipients who received their graft(s) from April 1, 2015 to July 31, 2018

  • Will analyze outcomes from April 1, 2014 to July 31, 2019

  • Patient list will be generated in Epic and Meditech

  • All data will be obtained from Epic and Meditech

  • All data will be collected retrospectively after the patient is discharged from the hospital

Study Design

Study Type:
Observational
Actual Enrollment :
585 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Everyone Poops: An Evaluation of the Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients
Actual Study Start Date :
Nov 4, 2019
Actual Primary Completion Date :
Aug 7, 2020
Actual Study Completion Date :
Aug 7, 2020

Outcome Measures

Primary Outcome Measures

  1. Incidence of C. Difficile infection (CDI) within one year post-transplant [April 1, 2014 to July 31, 2019]

    Incidence of C. Difficile infection within one year post-transplant for CDI post-transplant.

  2. Risk factors for CDI post-transplant - No.1 [April 1, 2014 to July 31, 2019]

    Risk factors transplanted organ

  3. Risk factors for CDI post-transplant - No.2 [April 1, 2014 to July 31, 2019]

    Origin of transplanted graft including age of donor

  4. Risk factors for CDI post-transplant No.-3 [April 1, 2014 to July 31, 2019]

    Induction agent used

  5. Risk factors for CDI post-transplant No.4 [April 1, 2014 to July 31, 2019]

    Acid suppression

  6. Risk factors for CDI post-transplant No.5 [April 1, 2014 to July 31, 2019]

    First time SOT recipient

  7. Risk factors for CDI post-transplant No.6 [April 1, 2014 to July 31, 2019]

    History of CDI in the year prior to transplant

  8. Risk factors for CDI post-transplant No.7 [April 1, 2014 to July 31, 2019]

    Co-infection with HIV/AIDS

  9. Risk factors for CDI post-transplant No.8 [April 1, 2014 to July 31, 2019]

    Length of hospital stay

  10. Risk factors for CDI post-transplant No. 9 [April 1, 2014 to July 31, 2019]

    Length of intensive care unit stay

  11. Risk factors for CDI post-transplant No.10 [April 1, 2014 to July 31, 2019]

    Intra-operative administration of blood products

  12. Risk factors for CDI post-transplant No. 11 [April 1, 2014 to July 31, 2019]

    Antibiotic use in the 90 days prior to infection

  13. Risk factors for CDI post-transplant No. 12 [April 1, 2014 to July 31, 2019]

    Antibiotic use in the 90 days post-transplant

  14. Risk factors for CDI post-transplant No, 13 [April 1, 2014 to July 31, 2019]

    Hospitalization in the 90 days prior to transplantation

  15. Risk factors for CDI post-transplant No, 14 [April 1, 2014 to July 31, 2019]

    Hospitalization in the 90 days post-transplant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018

  • Age >18 years old

Exclusion Criteria:
  • Age <18 years old

  • Loss to early death defined as within one week from transplantation

  • Patients whose primary address is in Puerto Rico

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jessica Rago Dallas Texas United States 75247

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Jessica Crotty, PharmD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT04637321
Other Study ID Numbers:
  • 059.PHA.2019.D
First Posted:
Nov 19, 2020
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022