NCT Number: NCT02492594
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.
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Notify Me6 month–90 year
All sexes
Observational
Hanusch Krankenhaus, Vienna, Austria
Samples from immunosuppressed patients with febrile neutropenia (NP - defined as fever ≥ 38.5ºC and <500 ANC) will be taken:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult study:
Pediatric study:
Exclusion criteria
Adult study:
Pediatric study:
Peripheral blood samples will be taken at 3-5 defined timepoints during febrile neutropenia:
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Invasive fungal diseases will be evaluated by developing improved diagnosis: technical validation of individual assays (PCR-based, NGS, and protein-based), validation of biomarkers in clinical specimens (MoAbs, proteinaceous infection markers) and optimized for time and parallel processing of samples by establishing a robust protocol to generate reproducible results, implementation of automated or semi-automated techniques and by use of defined quality control systems.
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
The frequency of invasive fungal disease in the paediatric and adult patient cohorts as well as in each individual patient will be elucidated.
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Progress and changes in healthcare practices provide opportunities for new and drug-resistant fungal pathogens emerging in hospital settings.
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Evaluation of potentially life-threatening fungal infections according to EORTC criteria.
St. Anna Kinderkrebsforschung
Other
Acronym: FUNGITECT
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