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

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ClinicalTrials.gov Identifier: NCT02492594
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Systemic Mycosis Other: Peripheral blood sampling

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.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
Study Start Date : February 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pediatric patients with febrile neutropenia
Peripheral blood sampling - samples from 200 pediatric 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

Adult patients with febrile neutropenia
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




Primary Outcome Measures :
  1. Number of patients with fungal DNAmia (as indicator of fungal infection) detected by new methodologies described in the proposal [ 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.

  2. Frequency of individual fungal pathogens during febrile neutropenia in high risk patients [ 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.

  3. Frequency of fungal pathogens resistant to commonly used antifungal agents [ 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.


Secondary Outcome Measures :
  1. Number of lethal fungal infections [ 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.


Biospecimen Retention:   Samples With DNA
Material that is not analyzed immediately will be stored until end of the study.


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Ages Eligible for Study:   6 Months to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Adult Patients between 18-90 years of age with high risk of invasive fungal infections (patients suffering from acute leukaemia and other tumour entities treated with intensive chemotherapy with neutropenic fever
  2. Pediatric patients between 0-18 years of age with high risk of invasive fungal infections ((patients suffering from acute leukaemia, patients undergoing allogeneic stem cell transplantation treated with intensive chemotherapy with neutropenic fever.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492594


Contacts
Contact: Thomas Lion, Prof MD PhD MSc 0043-1-40470 ext 4890 thomas.lion@ccri.at
Contact: Marlene Remely, PhD 0043-1-40470 ext 4491 marlene.remely@ccri.at

Locations
Austria
Medical University of Vienna, Department of Internal Medicine I Recruiting
Vienna, Austria, 1090
Contact: Susanne Herndlhofer    +43 1 40400 ext 45220    susanne.herndlhofer@meduniwien.ac.at   
Principal Investigator: Wolfgang Sperr, Prof MD         
Sub-Investigator: Gleixner Karoline, Ass Prof MD         
Sub-Investigator: Klaus Schmetterer, MD Phd         
Hospital Hietzing Active, not recruiting
Vienna, Austria, 1130
Hanusch Krankenhaus Recruiting
Vienna, Austria, 1140
Contact: Felix Keil, Prof MD       felix.keil@wgkk.at   
Contact: Elisabeth Koller, MD       elisabeth.koller@wgkk.at   
Wilhelminenspital Active, not recruiting
Vienna, Austria, 1160
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Gernot Engstler, MD    +43-1-40470 ext 9123    gernot.engstler@stanna.at   
Principal Investigator: Gernot Engstler, MD         
Netherlands
Princess Máxima Center for pediatric oncology Recruiting
Utrecht, Netherlands, 3508
Contact: Martine van Grotel, Dr.    +31 88 97 260 04    M.vanGrotel@prinsesmaximacentrum.nl   
Sponsors and Collaborators
St. Anna Kinderkrebsforschung
Investigators
Study Chair: Thomas Lion, Prof MD PhD MSc St. Anna Kinderkrebsforschung