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Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614145
First Posted: June 7, 2012
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University
  Purpose
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.

Condition
Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dieter Buchheidt, Heidelberg University:

Primary Outcome Measures:
  • Test sensitivity [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Aspergillus DNA samples

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Proven/probable CNS IA
Immunocompromised patients with proven/probable invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG
Possible/No CNS IA
Immunocompromised patients with possible/NoIA invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Immunocompromised patients at risk for invasive aspergillosis
Criteria

Inclusion Criteria:

  • Host factors
  • Informed consent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614145


Locations
Germany
Freiburg University Hospital
Freiburg, Baden-Würrtemberg, Germany, 79106
Mannheim University Hospital
Mannheim, Baden-Würrtemberg, Germany, 68167
Frankfurt (Oder) General Hospital
Frankfurt (Oder), Brandenburg, Germany, 15236
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Dieter Buchheidt, MD Germany: Mannheim University Hospital, University of Heidelberg
  More Information

Responsible Party: Dieter Buchheidt, Prof. Dr., Heidelberg University
ClinicalTrials.gov Identifier: NCT01614145     History of Changes
Other Study ID Numbers: CSF Aspergillus PCR
First Submitted: June 5, 2012
First Posted: June 7, 2012
Last Update Posted: May 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases