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Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing (EFFU-ASP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104479
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2014
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University

Study Description
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Brief Summary:
Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Condition or disease
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
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Study Type : Observational
Estimated 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 : March 31, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Test Sensitivity [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
only fungal DNA is investigated, no human DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
- 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,
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104479


Locations
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Germany
University Hospital Mannheim
Mannheim, Baden-Wuerrtemberg, Germany, 68167
Wuerzburg University Hospital
Wuerzburg, Bayern, Germany, 97080
Sponsors and Collaborators
Heidelberg University
Pfizer
Investigators
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Principal Investigator: Dieter Buchheidt, MD Universitätsmedizin Mannheim
More Information
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Publications:

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Responsible Party: Dieter Buchheidt, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT02104479    
Other Study ID Numbers: EFFU-ASP 2014
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Aspergillosis
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Mycoses