EFFU-ASP: Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

• Sponsor: Heidelberg University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02104479
• Collaborator: Pfizer (Industry)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 81.1
• Patients Per Site: 100
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis; Pleural Effusion; Immunosuppression

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Mar 31, 2014
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Immunocompromised Patients Immunocompromised patients with suspected IPA who have Pleural effusions act as the observed study population
Control Group Patients without Immunosuppression with pleural effusions

Outcome Measures

Primary Outcome Measures

1. Test Sensitivity [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Mannheim	Mannheim	Baden-Wuerrtemberg	Germany	68167
2	Wuerzburg University Hospital	Wuerzburg	Bayern	Germany	97080

Sponsors and Collaborators

• Heidelberg University
• Pfizer

Investigators

• Principal Investigator: Dieter Buchheidt, MD, Universitätsmedizin Mannheim

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dieter Buchheidt, MD, Heidelberg University
• ClinicalTrials.gov Identifier: NCT02104479
• Other Study ID Numbers: EFFU-ASP 2014
• First Posted: Apr 4, 2014
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Aspergillosis; Pleural Effusion

Study Results

No Results Posted as of Apr 20, 2020