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| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00443885 |
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 |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2013 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
gram negative bacteria
Inclusion Criteria:
Contacts and Locations| Contact: Brian Potoski, Pharm D | 412-648-6401 | potoskiba@upmc.edu |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | pakstisdl@dom.pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Brian Potoski, Pharm D 412-648-6401 potoskiba@upmc.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 pakstisdl@dom.pitt.edu | |
| Principal Investigator: Brian Potoski, Pharm D | |
| Principal Investigator: | Brian Potoski, Pharm D | University of Pittsburgh |
More Information
| Responsible Party: | Brian Potoski, Pharm D, Univeristy of Pittsburgh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00443885 History of Changes |
| Other Study ID Numbers: | PRO07020078 |
| Study First Received: | March 5, 2007 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
meropenem imipenem gram negative organism |
|
Imipenem Meropenem Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |