NCT02492594

Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: St. Anna Kinderkrebsforschung · Academic / Other
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Systemic Mycosis

Interventions

Type	Name	Description
OTHER	Peripheral blood sampling	Peripheral blood samples will be taken at 3-5 defined timepoints during febrile neutropenia: * 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

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2015-07-08
• Last updated: 2021-01-12

Locations

7 sites across 3 countries: Austria, Netherlands, Russia