Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Aspergillosis · Invasive Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00634049 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- isavuconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). |
25.0; 50.0; 14.3; 9.1; 0; 47.1 | — |
| SECONDARY Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT |
55.0; 75.0; 50.0; 33.3; 50.0; 68.8 | — |
| SECONDARY Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT |
30.0; 50.0; 4.8; 0; 0; 29.4 | — |
| SECONDARY Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT |
30.0; 25.0; 0; 10.0; 0; 25.0 | — |
| SECONDARY Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT |
60.0; 75.0; 50.0; 28.6; 25.0; 81.3 | — |
| SECONDARY Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT |
46.7; 66.7; 50.0; 28.6; 25.0; 69.2 | — |
| SECONDARY Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT |
35.0; 75.0; 40.0; 0; 40.0; 46.7 | — |
| SECONDARY All-cause Mortality Through Day 42 and Day 84 |
22.0; 16.1; 30.5; 20.7 | — |
| SECONDARY Safety - Overall Number of TEAEs |
139; 60; 89; 13; 19; 7 | — |
Summary
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
Data sourced from ClinicalTrials.gov (NCT00634049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.