Gram-negative Bacterial InfectionsNCT00394784
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
An observational study of Gram-negative Bacterial Infections, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-negative Bacterial Infections
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: positive gram negative bacteria isolates
Who may be able to join
- Patients with positive gram-negative bacteria
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.
Read the detailed description
Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.
- Conditions
- Gram-negative Bacterial Infections
- Keywords
- gram negative bacteria, culture, infection
- Medical subject headings
- Gram-Negative Bacterial Infections, Infections
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 posted1 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study terminated due to no enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-negative Bacterial InfectionsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Brian Potoski, University of Pittsburgh
- Investigators
- Brian Potoski, PharmD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394784
- Sponsor's protocol ID
- IRB0608120
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2006
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
- ClinicalTrials.gov ID
- NCT00394784
- Acronym / sponsor ID
- IRB0608120
- Conditions
- Gram-negative Bacterial Infections
- Keywords
- gram negative bacteria, culture, infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated due to no enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2006
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Nov 2006 (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.
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.
Detailed description
Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- positive gram negative bacteria isolates
Key inclusion criteria (1 listed)
- Patients with positive gram-negative bacteria
Key exclusion criteria (1 listed)
- Less than 18 years of age
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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, PharmD principal investigator
University of Pittsburgh
1 site 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 Bacterial Infections, run by University of Pittsburgh at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 11 Dec 2023.