Clinical trial NCT01576653: Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL
Official title: Prospective Clinical Evaluation of Bata-D-Glucan Assay for Diagnosis of Invasive Fungal Infection in Blood and Bronchoalveolar Lavage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Fungal Infection
Hematological Malignancy
Receipt of Solid Organ Transplant
Keywords: IFI
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI
timeFrame: 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.