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

NCT00394784 | Withdrawn DMC

• 1 other identifier: IRB0608120
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gram-negative Bacterial Infections

Keywords

gram negative bacteria; culture; infection

Outcome Measures

Primary Outcomes (1)

• dead or alive

  health status

  end of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

positive gram negative bacteria isolates

You may qualify if:

• Patients with positive gram-negative bacteria

You may not qualify if:

• Less than 18 years of age

Sponsors & Collaborators

• University of Pittsburgh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

MeSH Terms

Conditions

Gram-Negative Bacterial Infections; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Brian Potoski, PharmD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: November 1, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

US (1)