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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01576653
Other study ID # 23-343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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