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

NCT ID: NCT04637321

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

585 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-08-07

Brief Summary

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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

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* 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

Conditions

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Infection in Solid Organ Transplant Recipients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Solid 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Crotty, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Jessica Rago

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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059.PHA.2019.D

Identifier Type: -

Identifier Source: org_study_id

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