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

Hematological Malignancy Clinical Trial

Official title:

Prospective Clinical Evaluation of Bata-D-Glucan Assay for Diagnosis of Invasive Fungal Infection in Blood and Bronchoalveolar Lavage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576653
• Other study ID #: 23-343
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: May 2018

Study information

• Verified date: September 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Infections
• Invasive Fungal Infection
• Invasive Fungal Infections
• Mycoses
• Receipt of Solid Organ Transplant

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Robert Krause, MD

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI	Diagnostic potential of Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/ patients after solid organ transplantation and suspected IFI	6 months after intervention