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

Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01614145
• Other study ID #: CSF Aspergillus PCR
• Status: Enrolling by invitation
• Start date: September 2007
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Host factors

• Informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Aspergillosis
• Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis

Locations

Country	Name	City	State
Germany	Frankfurt (Oder) General Hospital	Frankfurt (Oder)	Brandenburg
Germany	Freiburg University Hospital	Freiburg	Baden-Würrtemberg
Germany	Mannheim University Hospital	Mannheim	Baden-Würrtemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test sensitivity		one year