Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265095
Recruitment Status : Unknown
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 22, 2010
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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 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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
Study Start Date : December 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

VRE bacteremia
VRE bacteremia patients

Primary Outcome Measures :
  1. all cause inhospital mortality [ Time Frame: 30days ]
    inhospital mortality as primary outcome, mean length of hospital stay around 30 days

Secondary Outcome Measures :
  1. VRE DNA load [ Time Frame: 14days ]
    VRE DNA load change during VRE treatment. Pre- and post-treatment compare.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
VRE bacteremia

Inclusion Criteria:

  • >18 y/o
  • VRE bacteremia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01265095

Contact: YuChung Chuang, MD 886-919121123

national Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: YuChung Chuang, MD    886-919121123   
Sub-Investigator: YuChung Chuang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: JannTay Wang, MD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01265095     History of Changes
Other Study ID Numbers: 201011023RB
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes