Trial document




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  DRKS00007593

Trial Description

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Title

In vitro analysis of combinatory effects of antifungals against highly resistant fungal pathogens

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Fusarium and mucormycetes are moulds that can cause life-threatening infections, especially in immuno-compromised patients. The best therapy is currently not established. In this study, the effects of a combination of antifungals against Fusarium species and mucormycetes will be studied.

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Brief Summary in Scientific Language

Fusarium species and mucormycetes can cause life threatening invasive infections. They are intrinsically resistant to most antifungals. The epidemiology and resistance patterns in Germany are currently unknown, as little data is available on these infections.
In this study, isolates from invasive infections will be identified by molecular methods and susceptibility tested according to the reference method of CLSI. Furthermore, the value of combination therapy will be evaluated in vitro (synergy testing).
It is planned to include 60-100 isolates from proven/probable infections (30-50 retrospectively, 30-50 prospectively).
Patient characteristics (age, risk factors, underlying disease etc.) will be documented after anonymization.

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Organizational Data

  •   DRKS00007593
  •   2014/12/05
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  •   yes
  •   No approval required according to EC
  •   2226-2014, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   B48.7 -  Opportunistic mycoses
  •   mucormycosis
  •   fusariosis
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Interventions/Observational Groups

  •   Fungal isolates obtained from patients with proven infection by Fusarium spp. or mucormycetes will be identified using molecular methods and subsequently susceptibility tested.
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Characteristics

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

Minimal inhibitory concentrations (MICs) of antifungals tested according to CLSI microdilution method (in vitro)

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Secondary Outcome

Synergy effects of antifungal combinations in vitro

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2015/01/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Proven/probable infection according to EORTC/MSG criteria by Fusarium spp. or mucormycetes

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Exclusion Criteria

none

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Addresses

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    • Robert Koch Institut Berlin
    • Nordufer 20
    • 13353  Berlin
    • Germany
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    • Institut für medizinische Mikrobiologie, Immunologie und HygieneUniversitätsklinikum Köln
    • Mr.  Dr.  Axel  Hamprecht 
    • Goldenfelsstr. 19-21
    • 50935  Köln
    • Germany
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    • Institut für Med. Mikrobiologie und Krankenhaushygiene Medizinische Hochschule Hannover
    • Mr.  Dr.  Ludwig  Sedlaczek 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • FG 16, Erreger von Pilz- und Parasiteninfektionen und Mykobakteriosen Robert Koch Institut Berlin
    • Ms.  Dr.  Katrin  Tintelnot 
    • Nordufer 20
    • 13353  Berlin
    • Germany
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    • FG 16, Erreger von Pilz- und Parasiteninfektionen und Mykobakteriosen Robert Koch-Institut
    • Mr.  Michael  Seibold 
    • Nordufer 20
    • 13353  Berlin
    • Germany
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    • Institut für medizinische Mikrobiologie, Immunologie und HygieneUniversitätsklinikum Köln
    • Mr.  Dr.  Axel  Hamprecht 
    • Goldenfelsstr. 19-21
    • 50935  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Robert Koch Institut
    • Nordufer 20
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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