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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Invasive Fungal Infection Hematological Malignancy Receipt of Solid Organ Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fungitell Assay in BAL

Intervention Type OTHER

Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI

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.

Group Type ACTIVE_COMPARATOR

Fungitell Assay in BAL

Intervention Type OTHER

Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI

Interventions

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Fungitell Assay in BAL

Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI

Intervention Type OTHER

Eligibility Criteria

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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