Status:
COMPLETED
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Basilea Pharmaceutica International Ltd
Conditions:
Aspergillosis
Invasive Fungal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 partici...
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...
Eligibility Criteria
Inclusion
- •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
- 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
Key Trial Info
Start Date :
April 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2016
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00634049
Start Date
April 22 2008
End Date
May 5 2016
Last Update
December 11 2024
Active Locations (96)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
City Of Hope National Medical Center
Duarte, California, United States, 91010
3
University of California Davis Health System
Sacramento, California, United States, 95817
4
California Pacific Medical Center
San Francisco, California, United States, 94110