Hematological Malignancy, Invasive Fungal Infection, Receipt of Solid Organ Transplant
Conditions
Keywords
IFI
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.
Interventions
OTHERFungitell Assay in BAL
Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI
Sponsors
Robert Krause, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI | 6 months after intervention | Diagnostic potential of Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/ patients after solid organ transplantation and suspected IFI |
Countries
Austria
Outcome results
None listed