Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
EFFU-ASP
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)
1 other identifier
observational
200
1 country
2
Brief Summary
Diagnostic accuracy of biomarker testing (galactomannan (GM), (1
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedStudy Start
First participant enrolled
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 20, 2020
April 1, 2020
6.8 years
March 27, 2014
April 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Test Sensitivity
one year
Study Arms (2)
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
Eligibility Criteria
\- Immunocompomised Patients based on the following conditions: 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,
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- missing informed consent
- contraindication for pleural centesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Pfizercollaborator
Study Sites (2)
University Hospital Mannheim
Mannheim, Baden-Wuerrtemberg, 68167, Germany
Wuerzburg University Hospital
Würzburg, Bavaria, 97080, Germany
Related 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, Durken 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.
PMID: 24108612BACKGROUND
Biospecimen
only fungal DNA is investigated, no human DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieter Buchheidt, MD
Universitätsmedizin Mannheim
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 4, 2014
Study Start
March 31, 2014
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04