Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis
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
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 20, 2020
April 1, 2020
13.3 years
June 8, 2012
April 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Test sensititivity
one year
Eligibility Criteria
Immunocompromised individuals
You may qualify if:
- Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis
You may not qualify if:
- proven CNS infections caused by pathogens other than Aspergillus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mannheim University Hospital
Mannheim, 68167, Germany
Biospecimen
fungal DNA from CSF samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieter Buchheidt, MD
Mannheim University Hospital, University of Heidelberg, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
September 1, 2007
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04