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

This study is currently recruiting participants.
Verified June 2017 by Brian Potoski, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443885
First Posted: March 7, 2007
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh
  Purpose
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
Gram Negative Organism

Study Type: Observational
Study Design: 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

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


Estimated Enrollment: 1000
Study Start Date: February 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
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.
  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:   Child, Adult, Senior
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.
  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): NCT00443885


Contacts
Contact: Brian Potoski, Pharm D 412-648-6401 potoskiba@upmc.edu
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Brian Potoski, Pharm D    412-648-6601    potoba@upmc.edu   
Contact: Diana Lynn Pakstis, RN, BSN    412-648-6553    dlp5@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian Potoski, Pharm D University of Pittsburgh
  More Information

Responsible Party: Brian Potoski, Pharm D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00443885     History of Changes
Other Study ID Numbers: PRO07020078
First Submitted: March 5, 2007
First Posted: March 7, 2007
Last Update Posted: June 12, 2017
Last Verified: June 2017

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