Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Immunosuppression Clinical Trial

— EFFU-ASP  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02104479
• Other study ID #: EFFU-ASP 2014
• Status: Enrolling by invitation
• Start date: March 31, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Immunosuppression
• Invasive Aspergillosis
• Pleural Effusion

Locations

Country	Name	City	State
Germany	University Hospital Mannheim	Mannheim	Baden-Wuerrtemberg
Germany	Wuerzburg University Hospital	Wuerzburg	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Reinwald M, Spiess B, Heinz WJ, Heussel CP, Bertz H, Cornely OA, Hahn J, Lehrnbecher T, Kiehl M, Laws HJ, Wolf HH, Schwerdtfeger R, Schultheis B, Burchardt A, Klein M, Dürken M, Claus B, Schlegel F, Hummel M, Hofmann WK, Buchheidt D. Aspergillus PCR-based investigation of fresh tissue and effusion samples in patients with suspected invasive Aspergillosis enhances diagnostic capabilities. J Clin Microbiol. 2013 Dec;51(12):4178-85. doi: 10.1128/JCM.02387-13. Epub 2013 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test Sensitivity		one year