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NCT01617759 Clinical Trial

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

Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01617759
Other study ID # Asp-PCR-CSF
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 2007
Est. completion date December 2020

Study information
Verified date April 2020
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis

Exclusion Criteria:

- proven CNS infections caused by pathogens other than Aspergillus

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Mannheim University Hospital Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Test sensititivity one year
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