Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates

This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.

Study Overview

• Status: Withdrawn
• Conditions: Gram-negative Bacterial Infections

Detailed Description

Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.

• Study Type: Observational

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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

positive gram negative bacteria isolates

Description

Inclusion Criteria:

• Patients with positive gram-negative bacteria

Exclusion Criteria:

• Less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dead or alive	health status	end of study

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Brian Potoski, PharmD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 30, 2006
• First Submitted That Met QC Criteria: October 31, 2006
• First Posted (Estimated): November 1, 2006

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: infection; culture; gram negative bacteria
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Gram-Negative Bacterial Infections
• Other Study ID Numbers: IRB0608120