Trials / Completed
CompletedNCT01576653
Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL
Prospective Clinical Evaluation of Bata-D-Glucan Assay for Diagnosis of Invasive Fungal Infection in Blood and Bronchoalveolar Lavage
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Robert Krause, MD · Academic / Other
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Fungitell Assay in BAL | Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2018-04-01
- Completion
- 2018-05-01
- First posted
- 2012-04-12
- Last updated
- 2021-09-28
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT01576653. Inclusion in this directory is not an endorsement.