Quinolone ResistanceNCT00518661
Risk Factors for Quinolone Resistance Among ESBL Producing Klebsiella Species
An observational study of Quinolone Resistance and ESBL, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quinolone Resistance, ESBL, Klebsiella Species
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 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: quinolone resistant
Who may be able to join
- must be quinolone resistant among ESBL producing klebsiella species
Who cannot join
- Those not meeting entry criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Risk Factors for Quinolone Resistance Among Extended-Spectrum Beta-Lactamase-Producing Klebsiella Species
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.
Read the detailed description
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.
- Conditions
- Quinolone Resistance, ESBL, Klebsiella Species, Infection
- Keywords
- quinolone resistance, ESBL, Klebsiella species, Infection
- Medical subject headings
- Klebsiella Infections, Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quinolone ResistanceStudies 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
- Retrospective
- Enrolment
- 500 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
- Brian Potoski, PharmD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518661
- Sponsor's protocol ID
- PRO07070356
- Other IDs
- investigator funding
- Status last verified
- Jun 2018
- First submitted
- 17 Aug 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
- Risk Factors for Quinolone Resistance Among Extended-Spectrum Beta-Lactamase-Producing Klebsiella Species
- ClinicalTrials.gov ID
- NCT00518661
- Acronym / sponsor ID
- PRO07070356
- Conditions
- Quinolone Resistance, ESBL, Klebsiella Species, Infection
- Keywords
- quinolone resistance, ESBL, Klebsiella species, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Aug 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.
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.
Detailed description
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- quinolone resistant
Key inclusion criteria (1 listed)
- must be quinolone resistant among ESBL producing klebsiella species
Key exclusion criteria (1 listed)
- Those not meeting entry criteria
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
Not reported in the source record.
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.
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 Quinolone Resistance and ESBL, 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: 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.
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.