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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01614145
First received: June 5, 2012
Last updated: December 8, 2015
Last verified: December 2015
  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 Heidelberg University:

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

Biospecimen Retention:   Samples With DNA
Aspergillus DNA 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)
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

Genders Eligible for Study:   Both
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
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: 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 
Study First Received: June 5, 2012
Last Updated: December 8, 2015
Health Authority: Germany: Mannheim University Hospital Ethics Comitee,University of Heidelberg, Germany

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

ClinicalTrials.gov processed this record on May 24, 2016