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

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ClinicalTrials.gov Identifier: NCT01614145
Recruitment Status : Enrolling by invitation
First Posted : June 7, 2012
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : September 2007
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

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

Biospecimen Retention:   Samples With DNA
Aspergillus DNA samples

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 7, 2012    Key Record Dates
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