Status unknownNCT02104479EFFU-ASPUpdated Apr 20, 2020

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

An observational study in Invasive Aspergillosis, Pleural Effusion and Immunosuppression, sponsored by Heidelberg University. Status unknown at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by Heidelberg University · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Enrolling by invitation — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years and older
Sex: All

Study summary

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

Read the detailed description

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

Conditions studied

Invasive Aspergillosis
Pleural Effusion
Immunosuppression

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In context

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 81 observational studies indexed under Aspergillosis.

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Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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,

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

Exclusion Criteria:

Age \< 18 years
missing informed consent
contraindication for pleural centesis

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 200 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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 researchers measure

Primary outcomes

Test Sensitivity
Time frame: one year

Study locations

2 sites

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

References and documents

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, 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. PubMed 24108612 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02104479
Lead sponsor: Heidelberg University
Collaborators: Pfizer
Responsible party: Dieter Buchheidt (MD, Heidelberg University) — Principal investigator
First posted: Apr 4, 2014
Start date: Mar 31, 2014
Primary completion: Dec 31, 2020 (estimated)
Completion: Dec 31, 2020 (estimated)
Last update: Apr 20, 2020

Study contacts

Dieter Buchheidt, MD

principal investigator · Universitätsmedizin Mannheim

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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