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

January 11, 2021 updated by: St. Anna Kinderkrebsforschung
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • St. Anna Children's Hospital
      • Vienna, Austria, 1160
        • Wilhelminenspital
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Internal Medicine I
      • Vienna, Austria, 1130
        • Hospital Hietzing
  • Netherlands
      • Utrecht, Netherlands, 3508
        • Princess Maxima Center for pediatric oncology
  • Russian Federation
      • Saint Petersburg, Russian Federation
        • First Saint-Petersburg Pavlov State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anna Kinderkrebsforschung

Investigators

  • Study Chair: Thomas Lion, Prof MD PhD MSc, St. Anna Kinderkrebsforschung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VB MD-AN-007-3D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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