Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Robert Krause, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01481038
First received: November 16, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.


Condition
Bloodstream Infection Due to Central Venous Catheter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections Using Biphasic PNA FISH and Gram Stain/AOLC Tests

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • development of crbsi [ Time Frame: Participants will be followed for the development of CRBSI during the duration of central venous catheter usage, an expected average of 1 year in hemodialysis patients and an expected average of six weeks in HSCT patients. ] [ Designated as safety issue: No ]
    There is only one outcome measure that is evaluated in two patient cohorts. Screening of catheter blood for microbial burden is performed during the whole study. Outcome measure is the development of CRBSI in these screened patients. Patients on hemodialysis using a CVC will be screened and observed for an sheduled time of approx. 1,5 years or until the CVC will be removed and hemodialysis no longer necessary. Patients undergoing HSCT will be screened and observed until CVC will be removed.


Biospecimen Retention:   Samples With DNA

Serum samples PBMCs Lung Tissue samples fungi


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group dialysis patients
Patient on hemodialysis with central venous catheter
Group hematology patients
Patients with hemato-oncologic underlying disease (plus/minus hematopoietic stem cell transplantation HSCT) and central venous catheter

Detailed Description:

Management of patients with hematologic malignancies, renal failure or diseases requiring intensive care often necessitates the use of central venous catheters (CVC). Beside obvious advantages CVCs bear a great risk for local or systemic infections. In the US estimated 250 000 catheter-related blood stream infection (CRBSIs) occur each year with mortality rates of 12-25%. Diagnosis of CRBSIs remains challenging as systemic clinical signs are unspecific and local signs of infection are often absent. Conventional methods for diagnosing CRBSIs require removal of the CVC. However, only 15% of CVCs removed in patients with clinical suspicion of CRBSI prove to be infected. It has been shown that CRBSI can also be detected by the differential time to positivity (DTP) method without catheter removal. The Gram stain/acridine-orange leukocyte cytospin (AOLC) test and PNA FISH test are another methods for the diagnosis of CRBSI that does not require the removal of the CVC and additionally have shown to be fast. Up to date methods for diagnosis of CRBSI are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. Since CRBSIs are not entirely preventable by strict hygiene measures earlier diagnosis of CRBSI in subclinical stages is desirable to avoid CRBSI-associated morbidity and mortality. Previously a pilot study showed that Gram stain/AOLC screening of CVCs in neutropenic patients was a useful test to predict the development of CRBSI on average 48 hours before the diagnosis was established by routine measures. In the pilot study Gram stain/AOLC screening test exhibited high specificity whereas sensitivity was moderate. PNA FISH is a specific slide-based staining technique that provides pathogen identification from blood samples containing a given amount of bacteria or fungi within a 1,5 hours. PNA FISH test has a slightly lower detection limit compared to Gram stain/AOLC which might therefore result in higher sensitivity when used as a screening tool. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.

  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

Patients undergoing hemodialysis using a central venous catheter and Patients with underlying hematooncologic disease with central venous catheters

Criteria

Inclusion Criteria:

  • Patients undergoing hemodialysis using a central venous catheter and
  • Patients with underlying hematooncologic disease with central venous catheters

Exclusion Criteria:

  • No central venous catheter
  • Current CRBSI
  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: NCT01481038

Contacts
Contact: Robert Krause, MD 0043 316 385 81796 robert.krause@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Stmk, Austria, 8036
Contact: Robert Krause, MD    0043 316 385 81796    robert.krause@medunigraz.at   
Principal Investigator: Robert Krause, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Robert Krause, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Robert Krause, MD, ao.Univ.Prof.Dr, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01481038     History of Changes
Other Study ID Numbers: CRBSI FFG Bridge
Study First Received: November 16, 2011
Last Updated: August 6, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
early detection
CRBSI

ClinicalTrials.gov processed this record on August 21, 2014