Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections (FUNGITECT)

St. Anna Kinderkrebsforschung

Status: Completed

Conditions: Systemic Mycosis

Treatments: Other: Peripheral blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT02492594

VB MD-AN-007-3D

Details and patient eligibility

About

Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for diagnostics designed to permit timely onset of appropriate treatment. The aim of the current clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of IFI, is to test newly developed diagnostic approaches to invasive fungal infections in relation to established procedures. The studies will be performed in a prospective, blinded fashion, and represent a work package within the FUNGITECT grant supported by the European Commission. The studies will focus on analyses of blood-samples from patients with febrile neutropenia during treatment of acute leukaemia and other tumour entities, and patients undergoing allogeneic stem cell transplantation treated with intensive chemotherapy.

Full description

Samples from immunosuppressed patients with febrile neutropenia (NP - defined as fever ≥ 38.5ºC and <500 ANC) will be taken:

• at the start of neutropenic fever
• after 24 hours
• after 48 hours
• before the start of antimycotic therapy, if pertinent
• at the end of antimycotic therapy, if pertinent

The results ot analyses by a panfungal PCR screening assay developed at our institution (European patent No 1960536) and methods newly developed during the FUNGITECT project will be compared with conventional methods for fungal diagnostics such as HR (High Resolution)-CT, serological testing, histology and fungal culture. Additionally, genomic approaches will be employed to investigate host- and pathogen-related factors of susceptibility, pathogenicity and antimycotic resistance.

Enrollment: 244 patients

Sex: All

Ages: 6 months to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Adult study:

• Patients between 18-90 years of age with high risk of invasive fungal infections
• signed informed consent

Pediatric study:

• patients between 0-18 years of age with high risk of invasive fungal infections
• signed informed consent

EXCLUSION CRITERIA

Adult study:

• pregnancy
• no consent

Pediatric study:

• no consent

Trial design

244 participants in 2 patient groups

Pediatric patients with febrile neutropenia

Description:

Peripheral blood sampling - samples from 200 pediatric patients with severe immunosuppression and neutropenic fever will be analyzed

Treatment:

Other: Peripheral blood sampling

Adult patients with febrile neutropenia

Description:

Peripheral blood sampling - samples from 200 adult patients with severe immunosuppression and neutropenic fever will be analyzed

Treatment:

Other: Peripheral blood sampling