Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL

This study is currently recruiting participants.
Verified January 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Robert Krause, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01576653
First received: April 10, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early initiation of appropriate antifungal therapy and thereby survival. Conventional culture is still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however, is low (50%) and time to results minimum 24 hours.

Therefore usage of serological tests detecting fungal antigens has increased dramatically over recent years. Main advantages of this new methods are rapid results and higher sensitivity when compared to conventional culture. One of the most promising serological marker currently used is beta-D-Glucan, which is a component of the fungal cell wall. ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of ß-D-Glucan in peripheral blood.

Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic performance of the Fungitell Assay in BAL from patients with solid organ transplant or hematologic malignancy.

In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as well as PCR will be determined and used as comparators for BDG performance.


Condition Intervention
Invasive Fungal Infection
Hematological Malignancy
Receipt of Solid Organ Transplant
Other: Fungitell Assay in BAL

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Clinical Evaluation of Bata-D-Glucan Assay for Diagnosis of Invasive Fungal Infection in Blood and Bronchoalveolar Lavage

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
    Diagnostic potential of Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/ patients after solid organ transplantation and suspected IFI


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No IFI
Bronchoscopy will be performed routinely in most patients with clinical suspicion of IFI. IFIs in patients will be retrospectively graded in possible, probable, proven and no IFI according to revised EORTC/MSG criteria. Patients that do not fulfill EORTC/MSG IFI criteria will serve as negative controls.
Other: Fungitell Assay in BAL
Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI
Active Comparator: IFI
Bronchoscopy will be performed routinely in most patients with clinical suspicion of IFI. IFIs in patients will be retrospectively graded in possible, probable, proven and no IFI according to revised EORTC/MSG criteria. Patients that do fulfill EORTC/MSG criteria of possible/probable/proven IFI will serve as study group.
Other: Fungitell Assay in BAL
Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • above 18 years of age
  • Bronchoscopy performed in clinical routine due to suspicion of IFI
  • Hematological malignancy or receipt of solid organ transplant/ICU

Exclusion Criteria:

  • below 18 years of age
  • No bronchoscopy performed
  • No Hematological malignancy nor receipt of solid organ transplant/ICU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576653

Contacts
Contact: Martin Hoenigl, MD +4331638581319 martin.hoenigl@medunigraz.at
Contact: Robert Krause, MD +4331638581796 robert.krause@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Martin Hoenigl, MD       martin.hoenigl@medunigraz.at   
Principal Investigator: Martin Hoenigl, MD         
Sub-Investigator: Robert Krause, MD         
Sponsors and Collaborators
Robert Krause, MD
  More Information

No publications provided

Responsible Party: Robert Krause, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01576653     History of Changes
Other Study ID Numbers: 23-343
Study First Received: April 10, 2012
Last Updated: January 29, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
IFI

Additional relevant MeSH terms:
Neoplasms
Mycoses
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014