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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01695499

Enrollment

200

Registered

2012-09-28

Start date

2012-08-31

Completion date

2020-12-31

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Diagnostics, INvasive Aspergillosis, Lung Infiltrates, Mechanical Ventilation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* immunocompetent patients (not fulfilling the criteria above)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results