CClinicalTrials.gg
CompletedNCT00443885Updated Jun 12, 2018

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

An observational study in Gram Negative Organism, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gram Negative Organism

Keywords

  • meropenem
  • imipenem
  • gram negative organism
03

In context

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

gram negative bacteria

Eligibility criteria

Inclusion Criteria:

  • Samples" for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
06

What researchers measure

Primary outcomes

  1. dead or alive

    health status

    Time frame: end of study

07

Study locations

2 sites
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • UPMC
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00443885
Lead sponsor
University of Pittsburgh
Responsible party
Brian Potoski (Pharm D, University of Pittsburgh) — Principal investigator
First posted
Mar 7, 2007
Start date
Feb 2007
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jun 12, 2018

Study contacts

Brian Potoski, Pharm D
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion