Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections

Systemic Mycosis Clinical Trial

— FUNGITECT  

Official title:

Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492594
• Other study ID #: VB MD-AN-007-3D
• Status: Completed
• Start date: March 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2021
• Source: St. Anna Kinderkrebsforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses
• Systemic Mycosis

Intervention

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

Locations

Country	Name	City	State
Austria	Hanusch Krankenhaus	Vienna
Austria	Hospital Hietzing	Vienna
Austria	Medical University of Vienna, Department of Internal Medicine I	Vienna
Austria	St. Anna Children's Hospital	Vienna
Austria	Wilhelminenspital	Vienna
Netherlands	Princess Máxima Center for pediatric oncology	Utrecht
Russian Federation	First Saint-Petersburg Pavlov State Medical University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Anna Kinderkrebsforschung

Countries where clinical trial is conducted

Austria,  Netherlands,  Russian Federation, 

References & Publications (1)

Landlinger C, Preuner S, Bašková 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 assa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Number of lethal fungal infections	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)

External Links

•   Link to the web page of the Children's Cancer Research Institute (St. Anna Kinderkrebsforschung), the sponsor of the study.