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

Heidelberg University

Status: Unknown

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01695499

Grant Pfizer ASPIRE Award (Other Grant/Funding Number)

BAL-Biomarker-ICU Study

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• immunocompetent patients (not fulfilling the criteria above)

Trial design

200 participants in 2 patient groups

Immunosuppressed ICU Patients with lung infiltrates

Description:

Immunosuppressed ICU Patients with lung infiltrates

Control Group

Description:

BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population.