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

April 17, 2020 updated by: Dieter Buchheidt, Heidelberg University

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)

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

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerrtemberg
      • Mannheim, Baden-Wuerrtemberg, Germany, 68167
        • University Hospital Mannheim
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Wuerzburg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Test Sensitivity
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Dieter Buchheidt, MD, Universitätsmedizin Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2014

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFU-ASP 2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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