Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Condition: Aspergillosis; Invasive Fungal Infections
MeSH terms: Mycoses; Aspergillosis; Invasive Fungal Infections
Intervention: isavuconazole
Intervention description: Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral
Intervention MeSH terms: Isavuconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: invasive fungal infections caused by rare molds, rare yeasts; BAL8557; Isavuconazole; Aspergillosis; or by dimorphic fungi; ASP9766

Summary:

      The purpose of this study is to investigate the efficacy and safety of isavuconazole in the
      treatment of renally impaired participants with invasive fungal infections caused by
      Aspergillus and participants with invasive fungal disease caused by rare fungi.
    

Eligibility criteria:

        Inclusion Criteria:

        •Participants meeting EORTC/MSG (European Organization for the Research and Treatment of
        Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive
        fungal disease) caused by rare moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens
        other than Aspergillus fumigatus or Candida species) whether renally impaired or not
        (including dialysis) who require primary therapy for their IFD at the time of enrollment.

        OR

        •Participants who had proven or probable zygomycosis, whether renally impaired or not
        (including dialysis), who require primary therapy. Zygomycosis must be documented by
        culture or histology / cytology.

        OR

        •Participants meeting EORTC/MSG definition of proven or culture positive probable IFD
        caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than
        Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were
        refractory to current treatment defined as,

          -  Clear documentation of progression of disease. Note: radiological progression only in
             association with white blood cell (WBC) count recovery was not acceptable.

          -  Failure to improve clinically despite receiving at least 7 days of standard antifungal
             regimen. Prior to enrolling patients who fell into this category, the Medical Monitor
             was contacted for approval.

        OR

        • Participants meeting EORTC/MSG definition of proven or culture positive probable IFD
        caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than
        Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were
        intolerant to current treatment for example:

          -  Doubling of serum creatinine value to higher than the upper limit of normal (ULN)
             within 48 hours.

          -  Serum creatinine > 2.0 mg/mL and current treatment with polyene or IV voriconazole.

          -  Other significant drug-related adverse reaction(s) to the current antifungal agent,
             resulting in discontinuation of the treatment, e.g., persistence of visual
             disturbance, allergic reaction, phototoxicity or severe infusion reaction
             (hypertensive crisis, severe chills or shock).

          -  Documented inability to achieve adequate blood levels of posaconazole, voriconazole or
             itraconazole.

        Exclusion Criteria:

          -  A known condition of the participants that may jeopardize adherence to the protocol
             requirements

          -  Participants who are unlikely to survive 30 days

          -  Participants with a body weight < 40 kg

          -  Women who are pregnant or breastfeeding