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

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ClinicalTrials.gov Identifier: NCT01617759
Recruitment Status : Enrolling by invitation
First Posted : June 12, 2012
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University

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.

Condition or disease
Aspergillosis Infection in an Immunocompromised Host

Detailed 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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
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




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

Biospecimen Retention:   Samples With DNA
fungal DNA from CSF samples


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:   No
Sampling Method:   Probability Sample
Study Population
Immunocompromised individuals
Criteria

Inclusion Criteria:

  • Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis

Exclusion Criteria:

  • proven CNS infections caused by pathogens other than Aspergillus

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): NCT01617759


Locations
Germany
Mannheim University Hospital
Mannheim, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital, University of Heidelberg, Germany

Responsible Party: Dieter Buchheidt, Senior Lecturer, Heidelberg University
ClinicalTrials.gov Identifier: NCT01617759     History of Changes
Other Study ID Numbers: Asp-PCR-CSF
First Posted: June 12, 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