Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
- Conditions
- Systemic Mycosis
- Interventions
- Other: Peripheral blood sampling
- Registration Number
- NCT02492594
- Lead Sponsor
- St. Anna Kinderkrebsforschung
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients with febrile neutropenia Peripheral blood sampling Peripheral blood sampling - samples from 200 adult patients with severe immunosuppression and neutropenic fever will be analyzed Pediatric patients with febrile neutropenia Peripheral blood sampling Peripheral blood sampling - samples from 200 pediatric patients with severe immunosuppression and neutropenic fever will be analyzed
- Primary Outcome Measures
Name Time Method Number of patients with fungal DNAmia (as indicator of fungal infection) detected by new methodologies described in the proposal 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.
Frequency of individual fungal pathogens during febrile neutropenia in high risk patients 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.
Frequency of fungal pathogens resistant to commonly used antifungal agents 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.
- Secondary Outcome Measures
Name Time Method Number of lethal fungal infections 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.
Trial Locations
- Locations (7)
Medical University of Vienna, Department of Internal Medicine I
🇦🇹Vienna, Austria
Hospital Hietzing
🇦🇹Vienna, Austria
Hanusch Krankenhaus
🇦🇹Vienna, Austria
Wilhelminenspital
🇦🇹Vienna, Austria
St. Anna Children's Hospital
🇦🇹Vienna, Austria
Princess Máxima Center for pediatric oncology
🇳🇱Utrecht, Netherlands
First Saint-Petersburg Pavlov State Medical University
🇷🇺Saint Petersburg, Russian Federation