Clinical trial NCT04637321: The Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients
Official title: Everyone Poops: An Evaluation of the Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection in Solid Organ Transplant Recipients
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of C. Difficile infection (CDI) within one year post-transplant
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant - No.1
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant - No.2
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.-3
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.4
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.5
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.6
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.7
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.8
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No. 9
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No.10
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No. 11
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No. 12
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No, 13
timeFrame: April 1, 2014 to July 31, 2019
measure: Risk factors for CDI post-transplant No, 14
timeFrame: April 1, 2014 to July 31, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Jessica Rago
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Jessica Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References: