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Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01265095
First received: December 10, 2010
Last updated: August 28, 2012
Last verified: August 2012

December 10, 2010
August 28, 2012
December 2010
December 2013   (final data collection date for primary outcome measure)
all cause inhospital mortality [ Time Frame: 30days ] [ Designated as safety issue: No ]
inhospital mortality as primary outcome, mean length of hospital stay around 30 days
Same as current
Complete list of historical versions of study NCT01265095 on ClinicalTrials.gov Archive Site
VRE DNA load [ Time Frame: 14days ] [ Designated as safety issue: No ]
VRE DNA load change during VRE treatment. Pre- and post-treatment compare.
Same as current
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Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

VRE bacteremia

Bacteremia
Not Provided
VRE bacteremia
VRE bacteremia patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >18 y/o
  • VRE bacteremia
Both
18 Years and older
No
Contact: YuChung Chuang, MD 886-919121123 weischuang@gmail.com
Taiwan
 
NCT01265095
201011023RB
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: JannTay Wang, MD National Taiwan University Hospital
National Taiwan University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP