Systemic MycosisFUNGITECTNCT02492594
Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
An observational study of Systemic Mycosis, run by St. Anna Kinderkrebsforschung at 7 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 6 months to 90 years
- Conditions the study is for
- Systemic Mycosis
- What is being tested?
- Peripheral blood sampling
- How many people
- 244 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Mar 2015to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Adult study:
- pregnancy
- no consent
- Pediatric study:
- no consent
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Austria5 sites
Medical University of Vienna, Department of Internal Medicine I
Vienna, 1090
Hospital Hietzing
Vienna, 1130
Hanusch Krankenhaus
Vienna, 1140
Wilhelminenspital
Vienna, 1160
St. Anna Children's Hospital
Vienna, A-1090
Netherlands1 site
Princess Máxima Center for pediatric oncology
Utrecht, 3508
Russia1 site
First Saint-Petersburg Pavlov State Medical University
Saint Petersburg
About this study
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.
Read the 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.
- Conditions
- Systemic Mycosis
- Being tested
- Peripheral blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with febrile neutropenia | Peripheral blood sampling - samples from 200 pediatric patients with severe immunosuppression and neutropenic fever will be analyzed Receives: 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 Receives: Other: Peripheral blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Secondary outcomes (1)
Number of lethal fungal infections
Evaluation of potentially life-threatening fungal infections according to EORTC criteria.
Measured: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMar 2015
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic MycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anna Kinderkrebsforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lion, Prof MD PhD MSc, Study chair, St. Anna Kinderkrebsforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492594
- Sponsor's protocol ID
- VB MD-AN-007-3D
- Acronym
- FUNGITECT
- Status last verified
- Jan 2021
- First submitted
- 28 May 2015
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20882044Lucini 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.
PubMed 39113112
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT02492594
- Acronym / sponsor ID
- FUNGITECT / VB MD-AN-007-3D
- Conditions
- Systemic Mycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- St. Anna KinderkrebsforschungUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with febrile neutropenia | – | Other: Peripheral blood samplingPeripheral blood sampling - samples from 200 pediatric patients with severe immunosuppression and neutropenic fever will be analyzed |
| Adult patients with febrile neutropenia | – | Other: Peripheral blood samplingPeripheral blood sampling - samples from 200 adult patients with severe immunosuppression and neutropenic fever will be analyzed |
Who may qualify
- Ages
- 6 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Patients between 18-90 years of age with high risk of invasive fungal infections
- signed informed consent
- patients between 0-18 years of age with high risk of invasive fungal infections
- signed informed consent
Key exclusion criteria (5 listed)
- pregnancy
- no consent
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplingPeripheral 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 | Other | Adult patients with febrile neutropenia, Pediatric patients with febrile neutropenia |
Primary outcome
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.
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.
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.
1 secondary outcome
Number of lethal fungal infections
Time frame: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Results publication: PubMed 20882044Landlinger 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.
- Derived from this study: PubMed 39113112Lucini 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.
- Link to the web page of the Children's Cancer Research Institute (St. Anna Kinderkrebsforschung), the sponsor of the study.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lion, Prof MD PhD MSc study chair
St. Anna Kinderkrebsforschung
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Mycosis, run by St. Anna Kinderkrebsforschung at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Netherlands, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492594, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.