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

Infection in Solid Organ Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637321
• Other study ID #: 059.PHA.2019.D
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: August 7, 2020

Study information

• Verified date: February 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection in Solid Organ Transplant Recipients
• Infections

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Jessica Rago	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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