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

Robert Krause, MD

Status: Completed

Conditions: Invasive Fungal Infection; Receipt of Solid Organ Transplant; Hematological Malignancy

Treatments: Other: Fungitell Assay in BAL

Study type: Interventional

Funder types: Other

Identifiers

NCT01576653

23-343

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

No IFI

Active Comparator group

Description:

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.

Treatment:

Other: Fungitell Assay in BAL

IFI

Active Comparator group

Description:

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.

Treatment:

Other: Fungitell Assay in BAL