Enterobacteriaceae InfectionsNCT00573235
Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli
An observational study of Enterobacteriaceae Infections, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterobacteriaceae Infections
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
Who may be able to join
- All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.
Read the detailed description
This is chart review at UPMC. There is no human interaction.
- Conditions
- Enterobacteriaceae Infections
- Keywords
- isolates, infection, E coli isolates
- Medical subject headings
- Enterobacteriaceae Infections, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteriaceae 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohei Doi, University of Pittsburgh
- Investigators
- Yohei Doi, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573235
- Sponsor's protocol ID
- PRO07090323
- Status last verified
- Jun 2018
- First submitted
- 12 Dec 2007
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli
- ClinicalTrials.gov ID
- NCT00573235
- Acronym / sponsor ID
- PRO07090323
- Conditions
- Enterobacteriaceae Infections
- Keywords
- isolates, infection, E coli isolates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Dec 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 purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.
Detailed description
This is chart review at UPMC. There is no human interaction.
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
- All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
Key inclusion criteria (1 listed)
- All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.
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
Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated.
Time frame: 5 years
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 14 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.
Yohei Doi, MD 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 Enterobacteriaceae 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 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 14 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 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 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?
Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated. (time frame: 5 years). 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 14 Jun 2018.