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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 8, 2015
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 leukemia or after hematopoietic stem cell transplantation.

Condition or disease Intervention/treatment Phase
Invasive Fungal Infections Other: Peripheral blood sampling Not Applicable

Detailed Description:

Samples from immunosuppressed patients with febrile neutropenia 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
Study Start Date : February 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pediatric patients with febrile neutropenia
Peripheral blood samples of up to 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, together with blood sampling for routine diagnostic purposes.

Active Comparator: Adult patients with febrile neutropenia
Peripheral blood samples of up to 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, together with blood sampling for routine diagnostic purposes.




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) ]
  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) ]
  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) ]

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) ]


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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
Criteria

Inclusion Criteria:

Adult study:

  • Patients between 18-90 years of age with high risk of invasive fungal infections (individuals with acute leukemia on chemotherapy/allogeneic stem cell transplant recipients),
  • signed informed consent

Pediatric study:

  • patients between 0-18 years of age with high risk of invasive fungal infections (individuals with acute leukemia on chemotherapy/allogeneic stem cell transplant recipients),
  • signed informed consent

Exclusion criteria:

Adult study:

  • pregnancy,
  • no signed informed consent
  • Pediatric study no signed informed 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 0043-1-40470 ext 4890 thomas.lion@ccri.at
Contact: Stefan Czurda, PHD 0043-1-40470 ext 4875 stefan.czurda@ccri.at

Locations
Austria
Hanusch Krankenhaus Recruiting
Vienna, Austria, 1140
Contact: Felix Keil, Prof MD       felix.keil@wgkk.at   
Contact: Elisabeth Koller, MD       elisabeth.koller@wgkk.at   
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Christina Peters, Prof MD PHD    +43-1-40470 ext 3106    christina.peters@stanna.at   
Principal Investigator: Christina Peters, Prof MD PHD         
Czech Republic
Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University Not yet recruiting
Prague, Czech Republic, 150 06
Contact: Petr Sedlacek, Prof MD PhD       petr.sedlacek@fnmotol.cz   
Principal Investigator: Petr Sedlacek, Prof MD PhD         
Sponsors and Collaborators
St. Anna Kinderkrebsforschung
Investigators
Study Director: Thomas Lion, Prof MD PHD St. Anna Kinderkrebsforschung

Additional Information:
Publications of Results:
Responsible Party: St. Anna Kinderkrebsforschung
ClinicalTrials.gov Identifier: NCT02492594     History of Changes
Other Study ID Numbers: VB MD-AN-007-3D
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections