Trial record 17 of 31 for:    Open Studies | "Aspergillosis"

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

This study is currently recruiting participants.
Verified March 2014 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01614145
First received: June 5, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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: September 2014
Estimated Primary Completion Date: September 2014 (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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614145

Locations
Germany
Freiburg University Hospital Recruiting
Freiburg, Baden-Würrtemberg, Germany, 79106
Contact: Hartmut Bertz, MD    +49-761-270-34060    hartmut.bertz@uniklinik-freiburg.de   
Principal Investigator: Hartmut Bertz, MD         
Mannheim University Hospital Recruiting
Mannheim, Baden-Würrtemberg, Germany, 68167
Contact: Dieter Buchheidt, MD    +49-621-383-4115    dieter.buchheidt@umm.de   
Contact: Mark Reinwald, MD    +49-621-383-4115    mark.reinwald@umm.de   
Principal Investigator: Dieter Buchheidt, MD         
Sub-Investigator: Mark Reinwald, MD         
Frankfurt (Oder) General Hospital Recruiting
Frankfurt (Oder), Brandenburg, Germany, 15236
Contact: Michael G Kiehl, MD    +49-335-5480    m.kiehl.km@klinikumffo.de   
Principal Investigator: Michael G Kiehl, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Dieter Buchheidt, MD Germany: Mannheim University Hospital, University of Heidelberg
  More Information

No publications provided

Responsible Party: Dieter Buchheidt, Prof. Dr., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01614145     History of Changes
Other Study ID Numbers: CSF Aspergillus PCR
Study First Received: June 5, 2012
Last Updated: March 27, 2014
Health Authority: Germany: Mannheim University Hospital Ethics Comitee,University of Heidelberg, Germany

Additional relevant MeSH terms:
Aspergillosis
Mycoses

ClinicalTrials.gov processed this record on April 17, 2014