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Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis

Sponsor
Heidelberg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01617759
Collaborator
(none)
200
Enrollment
1
Location
159
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostics. Therefore the performance of an established Aspergillus-specific nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients with hematological malignancies. Confirming the diagnosis is rarely accomplished as invasive procedures are impaired by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostic tools. Therefore the performance of an established Aspergillus-specific nested PCR assay in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Diagnostic Study on the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
    Study Start Date :
    Sep 1, 2007
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Test sensititivity [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis
    Exclusion Criteria:
    • proven CNS infections caused by pathogens other than Aspergillus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mannheim University Hospital Mannheim Germany 68167

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Principal Investigator: Dieter Buchheidt, MD, Mannheim University Hospital, University of Heidelberg, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dieter Buchheidt, Senior Lecturer, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01617759
    Other Study ID Numbers:
    • Asp-PCR-CSF
    First Posted:
    Jun 12, 2012
    Last Update Posted:
    Apr 20, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Aspergillosis

    Study Results

    No Results Posted as of Apr 20, 2020