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

Heidelberg University200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

INvasive Aspergillosis Mechanical Ventilation Lung Infiltrates Diagnostics Biomarker

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * underlying conditions (see above) * being on mechanical ventilation * lung infiltrates Exclusion Criteria: * immunocompetent patients (not fulfilling the criteria above)

Outcomes

Primary Outcomes

Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty

Evaluation of diagnostic accuracy of the combined biomarker approach

Time frame: 6 weeks