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OpenTrials
Completed

NCT Number: NCT04637321

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

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

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Key information

Conditions

Infection in Solid Organ Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessica Rago

Dallas, Texas, 75247, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solid organ transplant

Procedure

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

Primary outcomes

  1. Incidence of C. Difficile infection (CDI) within one year post-transplant

    Time frame: 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

    Time frame: April 1, 2014 to July 31, 2019

    Risk factors transplanted organ

  3. Risk factors for CDI post-transplant - No.2

    Time frame: April 1, 2014 to July 31, 2019

    Origin of transplanted graft including age of donor

  4. Risk factors for CDI post-transplant No.-3

    Time frame: April 1, 2014 to July 31, 2019

    Induction agent used

  5. Risk factors for CDI post-transplant No.4

    Time frame: April 1, 2014 to July 31, 2019

    Acid suppression

  6. Risk factors for CDI post-transplant No.5

    Time frame: April 1, 2014 to July 31, 2019

    First time SOT recipient

  7. Risk factors for CDI post-transplant No.6

    Time frame: 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

    Time frame: April 1, 2014 to July 31, 2019

    Co-infection with HIV/AIDS

  9. Risk factors for CDI post-transplant No.8

    Time frame: April 1, 2014 to July 31, 2019

    Length of hospital stay

  10. Risk factors for CDI post-transplant No. 9

    Time frame: April 1, 2014 to July 31, 2019

    Length of intensive care unit stay

  11. Risk factors for CDI post-transplant No.10

    Time frame: April 1, 2014 to July 31, 2019

    Intra-operative administration of blood products

  12. Risk factors for CDI post-transplant No. 11

    Time frame: 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

    Time frame: April 1, 2014 to July 31, 2019

    Antibiotic use in the 90 days post-transplant

  14. Risk factors for CDI post-transplant No, 13

    Time frame: April 1, 2014 to July 31, 2019

    Hospitalization in the 90 days prior to transplantation

  15. Risk factors for CDI post-transplant No, 14

    Time frame: April 1, 2014 to July 31, 2019

    Hospitalization in the 90 days post-transplant

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Everyone Poops: An Evaluation of the Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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