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

• Conditions: Diagnostics; Biomarker; INvasive Aspergillosis; Lung Infiltrates; Mechanical Ventilation

• Registration Number: NCT01695499
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• underlying conditions (see above)
• being on mechanical ventilation
• lung infiltrates

Exclusion Criteria

• immunocompetent patients (not fulfilling the criteria above)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty	6 weeks	Evaluation of diagnostic accuracy of the combined biomarker approach

Trial Locations

Locations (1)

Mannheim University Hospital; 🇩🇪 Mannheim, Germany