Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by National Taiwan University Hospital
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
  Purpose

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
Bacteremia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • VRE DNA load [ Time Frame: 14days ] [ Designated as safety issue: No ]
    VRE DNA load change during VRE treatment. Pre- and post-treatment compare.


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
VRE bacteremia
VRE bacteremia patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

VRE bacteremia

Criteria

Inclusion Criteria:

  • >18 y/o
  • VRE bacteremia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265095

Contacts
Contact: YuChung Chuang, MD 886-919121123 weischuang@gmail.com

Locations
Taiwan
national Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: YuChung Chuang, MD    886-919121123    weischuang@gmail.com   
Sub-Investigator: YuChung Chuang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: JannTay Wang, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01265095     History of Changes
Other Study ID Numbers: 201011023RB
Study First Received: December 10, 2010
Last Updated: August 28, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
VRE

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014