Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi (VITAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00634049
First received: March 5, 2008
Last updated: January 8, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Aspergillosis
Invasive Fungal Infections
Drug: isavuconazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). [ Time Frame: Day 42, 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.



Secondary Outcome Measures:
  • Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT [ Time Frame: Day 42, 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT [ Time Frame: Day 42, 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT [ Time Frame: Day 42, 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT [ Time Frame: Day 42, Day 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT [ Time Frame: Day 42, Day 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT [ Time Frame: Day 42, Day 84 and End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • All-cause Mortality Through Day 42 and Day 84 [ Time Frame: Baseline to End of Treatment (EOT [Day 180]) ] [ Designated as safety issue: No ]

    All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population

    End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.


  • Safety - Overall Number of TEAEs [ Time Frame: From the first study drug administration until 28 days after the last dose of study drug ] [ Designated as safety issue: No ]
    A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.


Enrollment: 149
Study Start Date: April 2008
Estimated Study Completion Date: January 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isavuconazole Drug: isavuconazole
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
Other Names:
  • ASP9766
  • BAL8557

Detailed Description:
Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634049

  Show 97 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00634049     History of Changes
Other Study ID Numbers: 9766-CL-0103  WSA-CS-003  2006-005003-33 
Study First Received: March 5, 2008
Results First Received: December 2, 2015
Last Updated: January 8, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Egypt: Ministry of Health and Population
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Lebanon: Ministry of Public Health
Mexico: Secretaria de Salud
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Aspergillosis
invasive fungal infections caused by rare molds, rare yeasts
or by dimorphic fungi
Isavuconazole
ASP9766
BAL8557

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Dermatomycoses
Hyalohyphomycosis
Infection
Skin Diseases
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on February 11, 2016