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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394784
First Posted: November 1, 2006
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh
  Purpose
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.

Condition
Gram-negative Bacterial Infections

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates

Resource links provided by NLM:


Further study details as provided by Brian Potoski, University of Pittsburgh:

Primary Outcome Measures:
  • dead or alive [ Time Frame: end of study ]
    health status


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.

Estimated Enrollment: 100
Study Start Date: December 2006
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
positive gram negative bacteria isolates
Criteria

Inclusion Criteria:

  • Patients with positive gram-negative bacteria

Exclusion Criteria:

  • Less than 18 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394784


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Brian Potoski, PharmD University of Pittsburgh
  More Information

Responsible Party: Brian Potoski, Pharm D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00394784     History of Changes
Other Study ID Numbers: IRB#0608120
First Submitted: October 30, 2006
First Posted: November 1, 2006
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Brian Potoski, University of Pittsburgh:
gram negative bacteria
culture
infection

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents