Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients

Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients; a Comparative Study With a Non-transplant Population

The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.

Study Overview

• Status: Completed
• Conditions: Gram Negative Infection

Detailed Description

We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

gram negative organisms

Description

Inclusion Criteria:

• All patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 15, 2006
• First Submitted That Met QC Criteria: March 15, 2006
• First Posted (Estimate): March 17, 2006

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: gram negative infection
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: IRB# 0602123