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

NCT ID: NCT00443885

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gram Negative Organism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brian Potoski

Pharm D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brian Potoski, Pharm D

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO07020078

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.