InfectionNCT00724919
A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli
An observational study of Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Taiwan.
Trial summary
To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 256 participants
- Where
- 2 sitesTaiwan
- Study dates
- Dec 2003to Apr 2004
- 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: patients admitted to ICU/burn unit
Who may be able to join
- All patients admitted or transferred to ICU/burn unit.
- Patients of either sex, 18 years of age or older. Exclusion
- Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) (A Post-Intervention Surveillance Study)
To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres
Read the detailed description
This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.
- Conditions
- Infection
- Keywords
- ESBL
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase
Measured: 48hours
Secondary outcomes (1)
The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startDec 2003
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724919
- Sponsor's protocol ID
- 0910X-101440
- Status last verified
- Aug 2008
- First submitted
- 23 Jul 2008
- Last updated
- 11 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) (A Post-Intervention Surveillance Study)
- ClinicalTrials.gov ID
- NCT00724919
- Acronym / sponsor ID
- 0910X-101440
- Conditions
- Infection
- Keywords
- ESBL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 30 Jul 2008 (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.
To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres
Detailed description
This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to ICU/burn unit
Key inclusion criteria (3 listed)
- All patients admitted or transferred to ICU/burn unit.
- Patients of either sex, 18 years of age or older. Exclusion
- Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours
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
The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase
Time frame: 48hours
1 secondary outcome
The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase
Time frame: 48hours
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 11 Aug 2008.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
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 Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Taiwan.
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 3 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 11 Aug 2008. 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 Taiwan. 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?
The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase (time frame: 48hours). 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 Aug 2008.