Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

• Conditions: Invasive Aspergillosis; Pleural Effusion; Immunosuppression

• Registration Number: NCT02104479
• Lead Sponsor: Heidelberg University

Brief Summary

Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Detailed Description

A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Study Timeline

• Study First Submitted: 2014-03-27
• Study Start: 2014-03-31
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• prolonged neutropenia > 10 d, patients
• after allogeneic stem cell transplantation or solid organ transplantation,
• Patients wth acute leukemia in induction treatment,
• patients witrh graft-versus-host-disease,
• patients under chronic immunusuppressive therapy such as ciclosporin,
• patients with HIV,
• patients with chronic steroid treatment

Exclusion Criteria

• Age < 18 years
• missing informed consent
• contraindication for pleural centesis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test Sensitivity	one year

Trial Locations

Locations (2)

University Hospital Mannheim; 🇩🇪 Mannheim, Baden-Wuerrtemberg, Germany

Wuerzburg University Hospital; 🇩🇪 Wuerzburg, Bayern, Germany