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Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC

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ClinicalTrials.gov Identifier: NCT00443885
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh

Brief Summary:
The isolate samples will be collected over a period of one year once IRB approval has been obtained. These isolates were collected as part of the patient's clinical care and once all clinical testing is complete, all isolates will be discarded. The honest broker of our area will collect the isolates and deidentify all information once all clinical testing is complete. The isolates will be obtained from the microbiology lab.

Condition or disease
Gram Negative Organism

Detailed Description:
The study will collect two hundred pseudomonas and 20 acinetobacter baumanti consecutive bacterial isolates from microbiology. These isolates are collected as part of the patient's clinical care and are discarded once all clinical testing is complete. The honest broker will obtain these samples after all clinical testing is complete. All isolates will be deidentified. These isolates will be tested using standardized susceptibility methods for meropenem and imipenem. The activity of doripenem, a carbapenem currently being studied, and arbekacin an aminoglycoside, will also be tested. The honest broker will also collect limited patient data including underlying condition, presence of a solid organ transplant, ward location, and antibiotic history over the three months prior to organism isolation. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms
Study Start Date : February 2007
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
gram negative bacteria
Criteria

Inclusion Criteria:

  • Samples" for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.

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): NCT00443885


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian Potoski, Pharm D University of Pittsburgh

Responsible Party: Brian Potoski, Pharm D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00443885     History of Changes
Other Study ID Numbers: PRO07020078
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Brian Potoski, University of Pittsburgh:
meropenem
imipenem
gram negative organism

Additional relevant MeSH terms:
Meropenem
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents