NCT02492594

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

May 28, 2015

Last Update Submit

January 11, 2021

Conditions

Systemic Mycosis

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)

Secondary Outcomes (1)

  • Number of lethal fungal infections

    until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)

Study Arms (2)

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

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

Interventions

Peripheral blood samplingOTHER

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 neutropeniaPediatric patients with febrile neutropenia

Eligibility Criteria

Age6 Months - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Adult study:
  • pregnancy
  • no consent
  • Pediatric study:
  • \- no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Medical University of Vienna, Department of Internal Medicine I

Vienna, 1090, Austria

Location

Hospital Hietzing

Vienna, 1130, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

Princess Máxima Center for pediatric oncology

Utrecht, 3508, Netherlands

Location

First Saint-Petersburg Pavlov State Medical University

Saint Petersburg, Russia

Location

Related Publications (2)

  • Landlinger C, Preuner S, Baskova L, van Grotel M, Hartwig NG, Dworzak M, Mann G, Attarbaschi A, Kager L, Peters C, Matthes-Martin S, Lawitschka A, van den Heuvel-Eibrink MM, Lion T. Diagnosis of invasive fungal infections by a real-time panfungal PCR assay in immunocompromised pediatric patients. Leukemia. 2010 Dec;24(12):2032-8. doi: 10.1038/leu.2010.209. Epub 2010 Sep 30.

    PMID: 20882044RESULT

  • Lucini C, Obrova K, Krickl I, Nogueira F, Kocmanova I, Herndlhofer S, Gleixner KV, Sperr WR, Frank T, Andrade N, Peters C, Engstler G, Dworzak M, Attarbaschi A, van Grotel M, van den Heuvel-Eibrink MM, Moiseev IS, Rogacheva Y, Zubarovskaya L, Zubarovskaya N, Pichler H, Lawitschka A, Koller E, Keil F, Mayer J, Weinbergerova B, Valent P, Lion T. Prevalence of fungal DNAemia mediated by putatively non-pathogenic fungi in immunocompromised patients with febrile neutropenia: a prospective cohort study. J Hematol Oncol. 2024 Aug 7;17(1):63. doi: 10.1186/s13045-024-01583-0.

    PMID: 39113112DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Material that is not analyzed immediately will be stored until end of the study.

Study Officials

  • Thomas Lion, Prof MD PhD MSc

    St. Anna Kinderkrebsforschung

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

July 8, 2015

Study Start

March 1, 2015

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

RU(1)AU(5)NL(1)