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

NCT01576653 | Completed

• 1 other identifier: 23-343
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IFI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No IFI

ACTIVE COMPARATOR

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

IFI

ACTIVE COMPARATOR

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

Interventions

Fungitell Assay in BAL OTHER

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

IFI; No IFI

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• below 18 years of age
• No bronchoscopy performed
• No Hematological malignancy nor receipt of solid organ transplant/ICU

Sponsors & Collaborators

• Robert Krause, MD: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (3)

• Prattes J, Raggam RB, Vanstraelen K, Rabensteiner J, Hoegenauer C, Krause R, Pruller F, Wolfler A, Spriet I, Hoenigl M. Chemotherapy-Induced Intestinal Mucosal Barrier Damage: a Cause of Falsely Elevated Serum 1,3-Beta-d-Glucan Levels? J Clin Microbiol. 2016 Mar;54(3):798-801. doi: 10.1128/JCM.02972-15. Epub 2015 Dec 30.

  PMID: 26719433 DERIVED

• Reischies FM, Raggam RB, Prattes J, Krause R, Eigl S, List A, Quehenberger F, Strenger V, Wolfler A, Hoenigl M. Urine Galactomannan-to-Creatinine Ratio for Detection of Invasive Aspergillosis in Patients with Hematological Malignancies. J Clin Microbiol. 2016 Mar;54(3):771-4. doi: 10.1128/JCM.02969-15. Epub 2015 Dec 23.

  PMID: 26699701 DERIVED

• Prattes J, Hoenigl M, Rabensteiner J, Raggam RB, Prueller F, Zollner-Schwetz I, Valentin T, Honigl K, Fruhwald S, Krause R. Serum 1,3-beta-d-glucan for antifungal treatment stratification at the intensive care unit and the influence of surgery. Mycoses. 2014 Nov;57(11):679-86. doi: 10.1111/myc.12221. Epub 2014 Jul 15.

  PMID: 25040144 DERIVED

MeSH Terms

Conditions

Invasive Fungal Infections; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: June 1, 2011
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

AU (1)