Comparison of Solid Organ Transplant

Gram-Negative Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04055922
• Other study ID #: 058.PHA.2017.D
• Status: Enrolling by invitation
• Start date: May 3, 2018
• Est. completion date: May 2021

Study information

• Verified date: April 2019
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

Exclusion Criteria:

• Missing data necessary to determine study outcomes

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Gram-negative Bacteremia
• Gram-Negative Bacterial Infections
• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia
• Multidrug-Resistant Organism
• Pneumonia

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Comparison of SOT	Comparison of SOT (liver and kidney) antibiograms with the hospital-wide antibiogram	Jan 1, 2012 - December 31, 2016
Secondary	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
Secondary	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