Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections

Bloodstream Infection Due to Central Venous Catheter Clinical Trial

Official title:

Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections Using Biphasic PNA FISH and Gram Stain/AOLC Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481038
• Other study ID #: CRBSI FFG Bridge
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: May 2, 2016
• Start date: October 2011
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bloodstream Infection Due to Central Venous Catheter
• Infection

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Stmk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of crbsi	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.	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.	No