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

Completed

• Conditions: Infection in Solid Organ Transplant Recipients

• Registration Number: NCT04637321
• Lead Sponsor: Methodist Health System

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

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-04
• Primary Completion: 2020-08-07
• Study Completion: 2020-08-07
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors for CDI post-transplant No.5	April 1, 2014 to July 31, 2019	First time SOT recipient
Risk factors for CDI post-transplant - No.2	April 1, 2014 to July 31, 2019	Origin of transplanted graft including age of donor
Risk factors for CDI post-transplant No. 12	April 1, 2014 to July 31, 2019	Antibiotic use in the 90 days post-transplant
Risk factors for CDI post-transplant No.7	April 1, 2014 to July 31, 2019	Co-infection with HIV/AIDS
Risk factors for CDI post-transplant - No.1	April 1, 2014 to July 31, 2019	Risk factors transplanted organ
Risk factors for CDI post-transplant No.4	April 1, 2014 to July 31, 2019	Acid suppression
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.
Risk factors for CDI post-transplant No.-3	April 1, 2014 to July 31, 2019	Induction agent used
Risk factors for CDI post-transplant No.6	April 1, 2014 to July 31, 2019	History of CDI in the year prior to transplant
Risk factors for CDI post-transplant No.8	April 1, 2014 to July 31, 2019	Length of hospital stay
Risk factors for CDI post-transplant No. 9	April 1, 2014 to July 31, 2019	Length of intensive care unit stay
Risk factors for CDI post-transplant No.10	April 1, 2014 to July 31, 2019	Intra-operative administration of blood products
Risk factors for CDI post-transplant No. 11	April 1, 2014 to July 31, 2019	Antibiotic use in the 90 days prior to infection
Risk factors for CDI post-transplant No, 13	April 1, 2014 to July 31, 2019	Hospitalization in the 90 days prior to transplantation
Risk factors for CDI post-transplant No, 14	April 1, 2014 to July 31, 2019	Hospitalization in the 90 days post-transplant

Trial Locations

Locations (1)

Jessica Rago; 🇺🇸 Dallas, Texas, United States