Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

NCT ID: NCT02104479

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Invasive Aspergillosis Pleural Effusion Immunosuppression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immunocompromised Patients

Immunocompromised patients with suspected IPA who have Pleural effusions act as the observed study population

No interventions assigned to this group

Control Group

Patients without Immunosuppression with pleural effusions

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Dieter Buchheidt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Buchheidt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Locations

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University Hospital Mannheim

Mannheim, Baden-Wuerrtemberg, Germany

Site Status

Wuerzburg University Hospital

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24108612 (View on PubMed)

Other Identifiers

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EFFU-ASP 2014

Identifier Type: -

Identifier Source: org_study_id

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