Clinical Trial Details

NCT ID: NCT01695512
Date Last Changed: March 27, 2014

Overview

Research Study Summary

Patients are needed to participate in a clinical research study to evaluate Invasive Aspergillosis, Acute Leukemia, Biomarkers or Stem Cell Transplantation

Research Study Title

Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, 1->3-β-D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL) and Blood Samples of Hematological High Risk Patients and to Detect Point Mutations Conferring Azole Resistance

Purpose

The aim of our prospective and multicentre diagnostic study is therefore to elucidate on the sensitivity and specificity rates of these serologic markers in combination with molecular tools (both an Aspergillus specific and a multifungal PCR based assay), as serologic mark-ers are not pathogen-specific, and furthermore to define species-specific cut-off values for BDG in BAL samples.

Additionally, if genomic material of Aspergillus fumigatus is detected by PCR in a clinical sample, we investigate fungal DNA for point mutations in the cyp51A gene mediating resis-tance against common mould-active triazoles with novel rapid, sensitive and specific, non-culture-based PCR-assays and sequencing to optimize antifungal treatment as early as pos-sible.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Heidelberg University
Duration
25 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • acute leukemia or after allogeneic stem cell transplantation

  • febrile neutropenia

  • lung infiltrates suggestive for fungal infection (halo sign. nodules, air-crescent sign)

Exclusion Criteria:

  • missing informed consent

  • other underlying diagnosis

Site Locations (1)

Country State City Zip Facility and Contact
Germany Mannheim 68167 University Hospital Mannheim
Dieter Buchheidt, MD
+49.621.383.4115
dieter.buchheidt@umm.de

Dieter Buchheidt, MD
Principal Investigator

Mark Reinwald, MD
Sub-Investigator

Contact

Dieter Buchheidt, MD
+49.621.383.4115
E-mail:

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