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NCT Number: NCT01576653

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

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.

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Key information

Conditions

Invasive Fungal Infection Bacterial Infections and Mycoses Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Infections Invasive Fungal Infections Mycoses Neoplasms Neoplasms by Site Receipt of Solid Organ Transplant

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fungitell Assay in BAL

Other

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

Primary outcomes

  1. Fungitell Assay from BAL in patients with hematologic malignancy or ICU patients/patients after solid organ transplantation and suspected IFI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Robert Krause, MD

Other

Registry information

Official study title

Prospective Clinical Evaluation of Bata-D-Glucan Assay for Diagnosis of Invasive Fungal Infection in Blood and Bronchoalveolar Lavage

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2012
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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