Clinical Trial Details

NCT ID: NCT01695499
Date Last Changed: March 27, 2014

Overview

Research Study Summary

Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates

Research Study Title

Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates

Purpose

The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.

As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.

To Learn more

Recruitment Details

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

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • underlying conditions (see above)

  • being on mechanical ventilation

  • lung infiltrates

Exclusion Criteria:

  • immunocompetent patients (not fulfilling the criteria above)

Site Locations (1)

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

Dieter Buchheidt, MD
Principal Investigator

Mark Reinwald, MD
Sub-Investigator

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