NCT04055922

Brief Summary

Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 3, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 2, 2020

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

August 12, 2019

Last Update Submit

December 30, 2019

Conditions

Gram-Negative Bacterial InfectionsGram-negative BacteremiaMultidrug-Resistant OrganismHospital-acquired PneumoniaHealthcare-associated Pneumonia

Outcome Measures

Primary Outcomes (3)

  • Creation of a liver transplant specific antibiogram

    Creation of a liver transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)

    Jan 1, 2012 - December 31, 2016

  • Creation of a kidney transplant specific antibiogram

    Creation of a kidney transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)

    Jan 1, 2012 - December 31, 2016

  • Comparison of SOT

    Comparison of SOT (liver and kidney) antibiograms with the hospital-wide antibiogram

    Jan 1, 2012 - December 31, 2016

Secondary Outcomes (2)

  • Creation of transplant antibiogram for subgroups

    Jan 1, 2012 - December 31, 2016

  • Identification of risk factors among liver transplant recipients

    Jan 1, 2012 - December 31, 2016

Eligibility Criteria

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

Solid organ transplant (SOT) recipients

You may qualify if:

  • years or older

You may not qualify if:

  • Missing data necessary to determine study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Gram-Negative Bacterial InfectionsHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsCross InfectionPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matt Crotty, PharmD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

May 3, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

January 2, 2020

Record last verified: 2019-04

Locations

US(1)