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

Sponsor

Robert Krause, MD (Other)

Overall Status

Completed

CT.gov ID

NCT01576653

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Invasive Fungal Infection Hematological Malignancy Receipt of Solid Organ Transplant	Other: Fungitell Assay in BAL	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI [6 months after intervention]
Diagnostic potential of Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/ patients after solid organ transplantation and suspected IFI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

Robert Krause, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Krause, MD, MD, Medical University of Graz

ClinicalTrials.gov Identifier:

NCT01576653

Other Study ID Numbers:

23-343

First Posted:

Apr 12, 2012

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Keywords provided by Robert Krause, MD, MD, Medical University of Graz

IFI

Additional relevant MeSH terms:

Infections

Mycoses

Invasive Fungal Infections

Hematologic Neoplasms

Study Results

No Results Posted as of Sep 28, 2021