Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples
April 17, 2020 updated by: Dieter Buchheidt, Heidelberg University
Diagnostic Study Evaluating the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baden-Würrtemberg
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Freiburg, Baden-Würrtemberg, Germany, 79106
- Freiburg University Hospital
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Mannheim, Baden-Würrtemberg, Germany, 68167
- Mannheim University Hospital
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Brandenburg
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Frankfurt (Oder), Brandenburg, Germany, 15236
- Frankfurt (Oder) General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Immunocompromised patients at risk for invasive aspergillosis
Description
Inclusion Criteria:
- Host factors
- Informed consent
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Proven/probable CNS IA
Immunocompromised patients with proven/probable invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG
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Possible/No CNS IA
Immunocompromised patients with possible/NoIA invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Test sensitivity
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dieter Buchheidt, MD, Germany: Mannheim University Hospital, University of Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSF Aspergillus PCR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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