Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Open Multicenter Diagnostic Study on the Accuracy of Biomarker Testing (Galactomannan (GM), (1-3)-β-D-glucan (BDG), Aspergillus-specific Polymerase Chain Reaction (PCR) Assay) in Pleural Effusion Samples of Immunocompromised Patients With Suspected Invasive Pulmonary Aspergillosis (IPA)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02104479

Acronym

EFFU-ASP

Enrollment

200

Registered

2014-04-04

Start date

2014-03-31

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

Immunosuppression, Invasive Aspergillosis, Pleural Effusion

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Test Sensitivity	one year

Countries

Germany

Outcome results