An observational study in Systemic Mycosis, sponsored by St. Anna Kinderkrebsforschung. Completed at 7 sites in 3 countries. Open to participants aged 6 Months to 90 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by St. Anna Kinderkrebsforschung · Observational
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.
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.
St. Anna Kinderkrebsforschung is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Adult study:
Pediatric study:
EXCLUSION CRITERIA
Adult study:
Pediatric study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Peripheral blood sampling - samples from 200 pediatric patients with severe immunosuppression and neutropenic fever will be analyzed
Other: Peripheral blood sampling
Peripheral blood sampling - samples from 200 adult patients with severe immunosuppression and neutropenic fever will be analyzed
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
Number of patients with fungal DNAmia (as indicator of fungal infection) detected by new methodologies described in the proposal
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)
Frequency of individual fungal pathogens during febrile neutropenia in high risk patients
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)
Frequency of fungal pathogens resistant to commonly used antifungal agents
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)
Number of lethal fungal infections
Evaluation of potentially life-threatening fungal infections according to EORTC criteria.
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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St. Anna Kinderkrebsforschung