Gram-Positive Bacterial InfectionsNCT00167960
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
An observational study of Gram-Positive Bacterial Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in South Korea.
Trial summary
To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Piperacillin/tazobactam and other β-lactam/β-lactamase
- How many people
- 1,500 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2005to not given
- 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
Who may be able to join
- All patients admitted to or transferred to the SICU.
- Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
- Provide written informed consent
Who cannot join
- Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
- Females who are pregnant and breast feeding
- Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
- Those who have already been participating other clinical study related with antibiotics.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.
To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Piperacillin/tazobactam and other β-lactam/β-lactamase
- Keywords
- Bacterial Infections
- Medical subject headings
- Gram-Positive Bacterial Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/tazobactam and other β-lactam/β-lactamaseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants
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
- NCT00167960
- Sponsor's protocol ID
- 0910X-101525
- Status last verified
- Mar 2007
- First submitted
- 11 Sep 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.
- ClinicalTrials.gov ID
- NCT00167960
- Acronym / sponsor ID
- 0910X-101525
- Conditions
- Gram-Positive Bacterial Infections
- Keywords
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- First posted
- 14 Sep 2005 (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 impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients admitted to or transferred to the SICU.
- Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
- Provide written informed consent
Key exclusion criteria (4 listed)
- Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
- Females who are pregnant and breast feeding
- Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
- Those who have already been participating other clinical study related with antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin/tazobactam and other β-lactam/β-lactamase | Drug | – |
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 15 Mar 2007.
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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 Gram-Positive Bacterial Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in South Korea.
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 4 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 15 Mar 2007. 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 South Korea. 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 15 Mar 2007.