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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01617759
First received: June 8, 2012
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
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
Aspergillosis
Infection in an Immunocompromised Host

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Test sensititivity [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
fungal DNA from CSF samples

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Dieter Buchheidt, Senior Lecturer, Heidelberg University
ClinicalTrials.gov Identifier: NCT01617759     History of Changes
Other Study ID Numbers: Asp-PCR-CSF 
Study First Received: June 8, 2012
Last Updated: December 8, 2015
Health Authority: Germany: Ministry of Health

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

ClinicalTrials.gov processed this record on May 01, 2016