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CompletedNCT04637321Updated Feb 4, 2022

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

An observational study in Infection in Solid Organ Transplant Recipients, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
585
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Infection in Solid Organ Transplant Recipients
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 585 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018

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

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
585 participants (actual)
Patient registry
No

Interventions

  • ProcedureSolid organ transplant

    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

06

What researchers measure

Primary outcomes

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

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

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

  2. Risk factors for CDI post-transplant - No.1

    Risk factors transplanted organ

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

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

    Origin of transplanted graft including age of donor

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

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

    Induction agent used

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

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

    Acid suppression

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

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

    First time SOT recipient

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

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

    History of CDI in the year prior to transplant

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

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

    Co-infection with HIV/AIDS

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

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

    Length of hospital stay

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

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

    Length of intensive care unit stay

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

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

    Intra-operative administration of blood products

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

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

    Antibiotic use in the 90 days prior to infection

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

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

    Antibiotic use in the 90 days post-transplant

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

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

    Hospitalization in the 90 days prior to transplantation

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

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

    Hospitalization in the 90 days post-transplant

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

07

Study locations

1 site
  • Jessica Rago
    Dallas, Texas 75247, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04637321
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
Nov 4, 2019
Primary completion
Aug 7, 2020
Completion
Aug 7, 2020
Last update
Feb 4, 2022

Study contacts

Jessica Crotty, PharmD
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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