Gram Negative OrganismNCT00443885
Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC
An observational study of Gram Negative Organism, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram Negative Organism
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: gram negative bacteria
Who may be able to join
- Samples" for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms
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.
- Conditions
- Gram Negative Organism
- Keywords
- meropenem, imipenem, gram negative organism
What is being measured
The primary outcome is the main question the study is designed to answer.
dead or alive
health status
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative OrganismStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Potoski, University of Pittsburgh
- Investigators
- Brian Potoski, Pharm D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443885
- Sponsor's protocol ID
- PRO07020078
- Status last verified
- Jun 2018
- First submitted
- 5 Mar 2007
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms
- ClinicalTrials.gov ID
- NCT00443885
- Acronym / sponsor ID
- PRO07020078
- Conditions
- Gram Negative Organism
- Keywords
- meropenem, imipenem, gram negative organism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- gram negative bacteria
Key inclusion criteria (1 listed)
- Samples" for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dead or alive
Time frame: end of study
health status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Potoski, Pharm D principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram Negative Organism, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dead or alive (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.