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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04637321
Enrollment
585
Registered
2020-11-19
Start date
2019-11-04
Completion date
2020-08-07
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection in Solid Organ Transplant Recipients

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

Interventions

PROCEDURESolid 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

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026