Infection in Solid Organ Transplant RecipientsNCT04637321

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

An observational study of Infection in Solid Organ Transplant Recipients, run by Methodist Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infection in Solid Organ Transplant Recipients
What is being tested?: Solid organ transplant
Type of treatment: Surgery or procedure
How many people: 585 participants
Where: 1 siteUnited States
Study dates: 4 Nov 2019to 7 Aug 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Jessica Rago
Dallas, Texas, 75247

Other trials in United States

About this study

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

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

Read the 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

Conditions: Infection in Solid Organ Transplant Recipients
Being tested: Solid organ transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Solid organ transplantProcedure or surgery
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 being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 20197 Aug 2020

First posted19 Nov 2020
Study start4 Nov 2019
Primary completion7 Aug 2020
Study completion7 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infection in Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 585 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04637321
Sponsor's protocol ID: 059.PHA.2019.D
Status last verified: Feb 2022
First submitted: 4 Nov 2019
Last updated: 4 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
Human Papillomavirus Infection, Anal HPV Infection
Active, not recruitingPhase 2
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
Immunization; Infection, Transplantation Infection
Not yet recruitingPhase 4
Letermovir for R+ Study
Kidney Transplant, Liver Transplant

All Infection in Solid Organ Transplant Recipients trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Everyone Poops: An Evaluation of the Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients
ClinicalTrials.gov ID: NCT04637321
Acronym / sponsor ID: 059.PHA.2019.D
Conditions: Infection in Solid Organ Transplant Recipients
Study type: Observational
Recruitment status: Completed
Enrolment: 585 participants (actual)
Lead sponsor: Methodist Health SystemUniversity, hospital or other
Study start: 4 Nov 2019 (actual)
Primary completion: 7 Aug 2020 (actual)
Study completion: 7 Aug 2020 (actual)
First posted: 19 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Solid organ transplantData 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	Procedure or surgery	–

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Individual participant dataSharing planned: Undecided

Related trials for Infection in Solid Organ Transplant Recipients

RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
Human Papillomavirus Infection, Anal HPV Infection
Active, not recruitingPhase 2
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
Immunization; Infection, Transplantation Infection
Not yet recruitingPhase 4
Letermovir for R+ Study
Kidney Transplant, Liver Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica Crotty, PharmD principal investigator

The Methodist Hospital Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infection in Solid Organ Transplant Recipients, run by Methodist Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of C. Difficile infection (CDI) within one year post-transplant (time frame: April 1, 2014 to July 31, 2019). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04637321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.