BacteremiaNCT01265095
Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
An observational study of Bacteremia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Dec 2013
- 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: VRE bacteremia
Who may be able to join
- >18 y/o
- VRE bacteremia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
national Taiwan University Hospital
Taipei, Taiwan, 100
YuChung Chuang, MD, 886-919121123, weischuang@gmail.com
YuChung Chuang, MD
About this study
The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. Two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug Administration for the treatment of serious VRE infections. Though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker.
Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. However, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. Real-time PCR has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. However, using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.
Read more
The objective of this study is to establish a quantitative method to measure the amounts of VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in blood results in higher mortality among patients with VRE BSIs.
Primers and probe of VRE Real-time PCR will be constructed first. The investigators will prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored. Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome and the association of bacteria load of VRE bacteremia will be analyzed.
- Conditions
- Bacteremia
- Keywords
- VRE
- Medical subject headings
- Bacteremia
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 |
|---|---|---|
| VRE bacteremia | VRE bacteremia patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause inhospital mortality
inhospital mortality as primary outcome, mean length of hospital stay around 30 days
Measured: 30days
Secondary outcomes (1)
VRE DNA load
VRE DNA load change during VRE treatment. Pre- and post-treatment compare.
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JannTay Wang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265095
- Sponsor's protocol ID
- 201011023RB
- Status last verified
- Aug 2012
- First submitted
- 10 Dec 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
- ClinicalTrials.gov ID
- NCT01265095
- Acronym / sponsor ID
- 201011023RB
- Conditions
- Bacteremia
- Keywords
- VRE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Dec 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.
The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. Two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug Administration for the treatment of serious VRE infections. Though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker.
Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. However, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. Real-time PCR has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. However, using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.
The objective of this study is to establish a quantitative method to measure the amounts of VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in blood results in higher mortality among patients with VRE BSIs.
Primers and probe of VRE Real-time PCR will be constructed first. The investigators will prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored. Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome and the association of bacteria load of VRE bacteremia will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRE bacteremia | – | –VRE bacteremia patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VRE bacteremia
Key inclusion criteria (2 listed)
- >18 y/o
- VRE bacteremia
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
all cause inhospital mortality
Time frame: 30days
inhospital mortality as primary outcome, mean length of hospital stay around 30 days
1 secondary outcome
VRE DNA load
Time frame: 14days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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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.
JannTay Wang, MD principal investigator
National Taiwan University 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 Bacteremia, run by National Taiwan University 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 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuChung Chuang, MD (886-919121123, weischuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause inhospital mortality (time frame: 30days). 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 30 Aug 2012.