Trial document





This trial has been registered retrospectively.
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  DRKS00006341

Trial Description

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Title

“Incidence and outcome of invasive fungal infections in pediatric patients with hematological malignancies and/or undergoing allogeneic hematopoietic stem cell transplantation – a prospective analysis in three major pediatric cancer centers (IFI-PED Study)”

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Trial Acronym

IFI-PED

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URL of the Trial

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Brief Summary in Lay Language

Current data on the incidence and on the outcome of invasive fungal infections in children with leukemia and/or hematopoietic stem cell transplantation are scarce. Most available data stem from studies performed prior to the availability of newer antifungal drugs. We plan to perform a prospective multicenter study on the frequency and prognosis of invasive fungal infections in children at high risk for invasive fungal infections and on the use of antifungal compounds in this population. We will collect data on patients´characteristics (such as age, underlying malignancy, chemotherapy), results of diagnostic procedures as well as on the use of antifungal compounds (such as for prophylaxis, empirical treatment or treatment of proven invasive fungal infections). These data will be analyzed regarding incidence of invasive fungal infections. In addition, we plan to characterize risk factors and periods of particular high risk for fungal infections and the current prognosis of these infectious complications when new antiufungal agents are available.

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Brief Summary in Scientific Language

Current data on the incidence and on the outcome of invasive fungal infections in children with hematological malignancies (HM) and/or allogeneic hematopoietic stem cell transplantation (HSCT) are scarce. Most available data stem from studies performed prior to the availability of newer triazoles such as voriconazole or echinocandins such as caspofungin and micafungin. In addition, many studies were performed retrospectively or are based on data of a single institution. We therefore plan to perform a prospective multicenter study on the frequency and prognosis of invasive fungal infections in children at high risk for invasive fungal infections and on the use of antifungal compounds in this population. We will collect data on patients´characteristics (such as age, underlying malignancy, chemotherapy, duration of neutropenia), results of diagnostic procedures, which may indicate or prove an invasive fungal infection (e.g., blood culture, galactomannan, imaging studies) as well as on the use of antifungal compounds (such as for prophylaxis, empirical treatment or treatment of proven invasive fungal infections). These data will be analyzed regarding incidence of possible, probable, and proven invasive fungal infections. In addition, we plan to characterize risk factors and periods of particular high risk for fungal infections and the current prognosis of these infectious complications when new antiufungal agents are available.

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Organizational Data

  •   DRKS00006341
  •   2014/07/21
  •   [---]*
  •   yes
  •   Approved
  •   348/13 , Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   Children with hematological malignancy (C91.0; C92.0)/children undergoing hematopoietic stem cell transplantation; proven, probable, and possible invasive fungal infection (B49)
  •   B49 -  Unspecified mycosis
  •   C92.0 -  Acute myeloblastic leukaemia [AML]
  •   C91.0 -  Acute lymphoblastic leukaemia [ALL]
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Interventions/Observational Groups

  •   Children with hematological malignancy/children undergoing hematopoietic stem cell transplantation; data captured include age, underlying malignancy, temperature; diagostic ruslts (e.g., galactomannan, imaging studies); administration of antifungal compounds
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

to describe the epidemiology of invasive fungal infections in three major pediatric cancer centers in Germany/Austria

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Secondary Outcome

1) to characterize risk factors and periods of risk for invasive fungal infections in different pediatric patient populations (e.g., children suffering from ALL, AML etc)
2) outcome of invasive fungal infections in pediatric cancer patients

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/01
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   0   Days
  •   18   Years
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Additional Inclusion Criteria

• Children and adolescents 0 to <18 years who are diagnosed with acute lymphoblastic leukemia, acute myeloid leukemia, relapse of acute leukemia or receive an allogeneic hematopoietic stem cell transplantation in the University Children´s Hospitals of Frankfurt, Münster or in St. Anna Kinderspital, Vienna, respectively
• Diagnosis of the malignancy/ transplantation between April 1, 2014 and March 31, 2016
• Written informed consent is mandatory for enrollment in the study.

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Exclusion Criteria

• Patients without written informed will be excluded from the study.

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Addresses

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    • Pädiatrische Hämatologie und OnkologieKlinik für Kinder- und JugendmedizinJohann Wolfgang Goethe Universität
    • Mr.  Prof. Dr.  Thomas  Lehrnbecher 
    • Theodor Stern Kai 7
    • 60590  Frankfurt
    • Germany
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    • St. Anna Kinderspital
    • Mr.  Priv-Doz. Dr.  Andishe  Attarbaschi 
    • Kinderspitalgasse 6
    • 1090  Wien
    • Austria
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    • Pädiatrische Hämatologie und OnkologieKlinik für Kinder- und JugendmedizinJohann Wolfgang Goethe Universität
    • Mr.  Prof. Dr.  Thomas  Lehrnbecher 
    • Theodor Stern Kai 7
    • 60590  Frankfurt
    • Germany
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    • Pädiatrische Hämatologie und OnkologieKlinik für Kinder- und JugendmedizinJohann Wolfgang Goethe Universität
    • Mr.  Prof. Dr. med.  Thomas  Lehrnbecher 
    • Theodor Stern Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.