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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01617759

Enrollment

200

Registered

2012-06-12

Start date

2007-09-30

Completion date

2020-12-31

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis, Infection in an Immunocompromised Host

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis

Exclusion criteria

* proven CNS infections caused by pathogens other than Aspergillus

Design outcomes

Primary

Measure	Time frame
Test sensititivity	one year

Countries

Germany

Outcome results