Comparison of Solid Organ Transplant

Comparison of Solid Organ Transplant Specific and Hospital-wide Gram-Negative Antibiograms

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.

Study Overview

• Status: Unknown
• Conditions: Gram-Negative Bacterial Infections; Hospital-acquired Pneumonia; Healthcare-associated Pneumonia; Gram-negative Bacteremia; Multidrug-Resistant Organism

Detailed Description

There is limited guidance for empiric antimicrobial therapy in this population. Local epidemiology plays a voluble role in managing infections empirically within the hospital setting. Antibiograms can serve as a critical tool in optimizing empiric antimicrobial decisions. Refining antibiogram data to specific populations such as SOT patients may allow for timelier and appropriate empiric use of antimicrobials, and improve clinical outcomes.

Time to appropriate therapy (antimicrobial testing susceptible in vitro to the pathogen identified) is of vital importance in management of serious infections. SOT may have different resistance rates at Methodist Dallas Medical Center making the applicability of the yearly hospital-wide antibiogram unknown for use in this specialized patient population. A SOT-Specific antibiogram may highlight common resistance patterns identified in pathogens seen in this patient population. Additionally, this investigation may further emphasize the importance of antimicrobial stewardship activities such as: appropriate empiric antibacterial decisions, de-escalation, and effective durations of therapy.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Solid organ transplant (SOT) recipients

Description

Inclusion Criteria:

• 18 years or older

Exclusion Criteria:

• Missing data necessary to determine study outcomes

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of transplant antibiogram for subgroups	Creation of transplant antibiogram for subgroups of patients including the following: ICU patients, Kidney transplant urinary tract infections (UTI), SOT bloodstream infections (BSI)	Jan 1, 2012 - December 31, 2016
Identification of risk factors among liver transplant recipients	Identification of risk factors among liver transplant recipients for vancomycin-resistant enterococci infections	Jan 1, 2012 - December 31, 2016

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Matt Crotty, PharmD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (ACTUAL): August 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Sepsis; Healthcare-Associated Pneumonia; Pneumonia; Bacteremia; Bacterial Infections; Gram-Negative Bacterial Infections
• Other Study ID Numbers: 058.PHA.2017.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No