NCT04637321

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

November 4, 2019

Last Update Submit

February 3, 2022

Conditions

Infection in Solid Organ Transplant Recipients

Outcome Measures

Primary Outcomes (15)

  • 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

Interventions

Solid organ transplantPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018

You may qualify if:

  • Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018
  • Age \>18 years old

You may not qualify if:

  • Age \<18 years old
  • Loss to early death defined as within one week from transplantation
  • Patients whose primary address is in Puerto Rico

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessica Rago

Dallas, Texas, 75247, United States

Location

Study Officials

  • Jessica Crotty, PharmD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 19, 2020

Study Start

November 4, 2019

Primary Completion

August 7, 2020

Study Completion

August 7, 2020

Last Updated

February 4, 2022

Record last verified: 2022-02

Locations

US(1)