InfectionNCT01201031
Reduction of Nosocomial Vancomycin -Resistant Enterococci (VRE) Colonization and Infection by Active Surveillance and Intervention of Infection Control
An observational study of Infection, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Infection
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Feb 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to RCC unit , and these patients received active surveillance of VRE colinization
Who may be able to join
- all patients admitted to RCC unit
Who cannot join
- if the patients or family refused the exam of anal swab .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Nosocomial VRE Colonization and Infection by Active Surveillance and Intervention of Infection Control (no)
Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission.
This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education.
Read more
Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.
The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.
- Conditions
- Infection
- Keywords
- for the active surveillance of VRE colinization and infection
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionFeb 2011
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
- Case only
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Sen Lee, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201031
- Sponsor's protocol ID
- 98105
- Status last verified
- Mar 2011
- First submitted
- 12 Sep 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Nosocomial VRE Colonization and Infection by Active Surveillance and Intervention of Infection Control (no)
- ClinicalTrials.gov ID
- NCT01201031
- Acronym / sponsor ID
- 98105
- Conditions
- Infection
- Keywords
- for the active surveillance of VRE colinization and infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Sep 2010 (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.
Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission.
This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education.
Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.
The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to RCC unit , and these patients received active surveillance of VRE colinization
Key inclusion criteria (1 listed)
- all patients admitted to RCC unit
Key exclusion criteria (1 listed)
- if the patients or family refused the exam of anal swab .
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 16 Mar 2011.
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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.
Wen-Sen Lee principal investigator
Taipei Medical University WanFang Hospital
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 Infection, run by Taipei Medical University WanFang Hospital at 1 site 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 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 16 Mar 2011. 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 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.
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 16 Mar 2011.