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

Study Overview
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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

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

Conditions
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Infection in Solid Organ Transplant Recipients

Intervention / Treatment
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* Procedure: Solid organ transplant


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

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