Aspergillosis, Invasive Fungal Infections
Conditions
Keywords
invasive fungal infections caused by rare molds, rare yeasts, BAL8557, Isavuconazole, Aspergillosis, or by dimorphic fungi, ASP9766
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 participants with invasive fungal disease caused by rare fungi.
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.
Interventions
DRUGisavuconazole
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
Sponsors
Basilea Pharmaceutica International Ltd
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42, 84 and End of Treatment (EOT [Day 180]) | 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
| Measure | Time frame | Description |
|---|---|---|
| Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | 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 | Day 42, 84 and End of Treatment (EOT [Day 180]) | 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 | Day 42, 84 and End of Treatment (EOT [Day 180]) | 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 | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | 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 | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | 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 | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | 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 | Baseline to End of Treatment (EOT [Day 180]) | 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 | From the first study drug administration until 28 days after the last dose of study drug | 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. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Egypt, France, Germany, India, Israel, Lebanon, Mexico, Poland, Russia, South Africa, South Korea, Thailand, United States
Participant flow
Recruitment details
Consenting adult participants with proven, probable or possible invasive aspergillosis and renally impaired (RI) or of participants with invasive fungal disease (IFD) caused by rare moulds, yeasts or dimorphic fungi meeting the inclusion and none of the exclusion criteria were considered for entry into the study.
Pre-assignment details
Analysis and interpretation of the results was pathogen dependent and each pathogen was quite rare, therefore it was not feasible to enroll a sufficient number of participants in a randomized controlled trial to power the study adequately to allow statistical comparisons.
Participants by arm
| Arm | Count |
|---|---|
| Isavuconazole Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) \[or per os (PO)\] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria. | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Died prior to receiving study drug | 1 |
| Overall Study | Never received study drug | 1 |
| Overall Study | Screening failure | 1 |
Baseline characteristics
| Characteristic | Isavuconazole |
|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 16.78 |
| Allogeneic Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) No | 120 participants |
| Allogeneic Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Yes | 26 participants |
| Corticosteroid use No | 111 participants |
| Corticosteroid use Yes | 35 participants |
| Hematologic malignancy No | 83 participants |
| Hematologic malignancy Yes | 63 participants |
| Neutropenic Missing | 42 participants |
| Neutropenic No | 66 participants |
| Neutropenic Yes | 38 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 22 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 124 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Region of Enrollment Belgium | 13 participants |
| Region of Enrollment Brazil | 20 participants |
| Region of Enrollment Germany | 4 participants |
| Region of Enrollment India | 5 participants |
| Region of Enrollment Israel | 21 participants |
| Region of Enrollment Korea, Republic of | 2 participants |
| Region of Enrollment Lebanon | 1 participants |
| Region of Enrollment Mexico | 8 participants |
| Region of Enrollment Russian Federation | 2 participants |
| Region of Enrollment Thailand | 14 participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 100 Participants |
| T-cell immunosuppressant use Missing | 37 participants |
| T-cell immunosuppressant use No | 48 participants |
| T-cell immunosuppressant use Yes | 61 participants |
| Therapy status Intolerant | 12 participants |
| Therapy status Missing | 3 participants |
| Therapy status Primary Therapy | 93 participants |
| Therapy status Refractory | 38 participants |
| Uncontrolled malignancy No | 100 participants |
| Uncontrolled malignancy Yes | 46 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 54 / 59 | 68 / 87 |
| serious Total, serious adverse events | 43 / 59 | 46 / 87 |
Outcome results
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).
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.
Time frame: Day 42, 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 25.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 30.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 30.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 25.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 66.7 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 50.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 31.6 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 14.3 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 9.5 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 36.4 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 9.1 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 36.4 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 20.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 20.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 41.2 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 47.1 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 64.7 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 28.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 28.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 28.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 44.8 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 41.4 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 64.3 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 36.4 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 36.4 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 72.7 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42- Success Rate | 13.3 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | End of Treatment (EOT) - Success Rate | 14.3 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 84 - Success Rate | 13.3 percentage of participants |
Secondary
All-cause Mortality Through Day 42 and Day 84
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.
Time frame: Baseline to End of Treatment (EOT [Day 180])
Population: Intent-To-Treat population (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | All-cause Mortality Through Day 42 and Day 84 | All-cause Mortality Through Day 42 | 22.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | All-cause Mortality Through Day 42 and Day 84 | All-cause Mortality Through Day 84 | 30.5 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | All-cause Mortality Through Day 42 and Day 84 | All-cause Mortality Through Day 42 | 16.1 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | All-cause Mortality Through Day 42 and Day 84 | All-cause Mortality Through Day 84 | 20.7 percentage of participants |
Secondary
Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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.
Time frame: Day 42, 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 55.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 55.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 45.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 25.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 66.7 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 75.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 55.6 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 50.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 40.0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 22.2 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 33.3 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 22.2 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 50.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 50.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 50.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 62.5 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 68.8 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 81.3 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 71.4 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 85.7 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 42.9 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 82.8 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 79.3 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 82.1 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 70.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 70.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 70.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 42.9 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 38.5 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 35.7 percentage of participants |
Secondary
Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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.
Time frame: Day 42, Day 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 60.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 60.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 55.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 55.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 75.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 75.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 42.9 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 50.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 21.4 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 28.6 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 28.6 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 25.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 25.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 20.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 66.7 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 62.5 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 81.3 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 81.3 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 85.7 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 71.4 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 42.9 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 82.2 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 75.9 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 79.3 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 70.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 70.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 70.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 50.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 42.9 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 35.7 percentage of participants |
Secondary
Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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.
Time frame: Day 42, 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 30.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 35.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 35.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 25.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 66.7 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 50.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 31.6 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 4.8 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 9.5 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 36.4 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 27.3 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 40.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 40.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 35.3 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 29.4 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 70.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 28.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 28.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 28.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 27.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 27.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 53.6 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 45.5 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 45.5 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 81.8 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 13.3 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 14.3 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 13.3 percentage of participants |
Secondary
Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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.
Time frame: Day 42, Day 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 46.7 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 50.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 44.4 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 50.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 66.7 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 66.7 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 42.9 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 50.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 21.4 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 28.6 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 28.6 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 25.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 25.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 20.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 66.7 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 64.3 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 69.2 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 78.6 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 83.3 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 66.7 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 42.9 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 80.0 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 70.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 76.9 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 25.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 50.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 50.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 18.2 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 25.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 33.3 percentage of participants |
Secondary
Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT
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.
Time frame: Day 42, 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 30.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 15.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 20.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 25.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 66.7 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 25.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 16.7 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 4.8 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 20.0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 10.0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 20.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 20.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 20.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 6.3 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 25.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 50.0 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 16.7 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 0 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 0 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 28.6 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 21.4 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 33.3 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 10.0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 10.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42- Success Rate | 7.1 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | End of Treatment (EOT) - Success Rate | 7.7 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 84 - Success Rate | 14.3 percentage of participants |
Secondary
Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT
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.
Time frame: Day 42, Day 84 and End of Treatment (EOT [Day 180])
Population: Modified Intent-To-Treat population (mITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 35.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 35.0 percentage of participants |
| mITT - Aspergillus [Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 40.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 50.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 50.0 percentage of participants |
| mITT - Aspergillus [Not Renally Impaired] | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 75.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 30.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 40.0 percentage of participants |
| mITT - Mucorales (Primary Therapy) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 25.0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 22.2 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 0 percentage of participants |
| mITT - Mucorales (Refractory) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 11.1 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 40.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 40.0 percentage of participants |
| mITT - Mucorales (Intolerant) | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 20.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 40.0 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 46.7 percentage of participants |
| mITT- Other Filamentous Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 33.3 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 20.0 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 40.0 percentage of participants |
| mITT- Other Mould Species Only | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 20.0 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 37.0 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 32.1 percentage of participants |
| mITT- Other Dimorphic Fungi | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 55.6 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 0 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 9.1 percentage of participants |
| mITT- Other Non-Candida Yeast | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 10.0 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42 | 28.6 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | End of Treatment (EOT) | 14.3 percentage of participants |
| mITT-Other Mixed Infection | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 84 | 7.1 percentage of participants |
Secondary
Safety - Overall Number of TEAEs
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.
Time frame: From the first study drug administration until 28 days after the last dose of study drug
Population: The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Study Drug-Related TEAEs | 60 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | TEAEs | 139 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Serious TEAEs | 89 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Study Drug-Related Serious TEAEs | 13 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | TEAEs Leading to Permanent Discontinuation of Stud | 19 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Study Drug TEAEs Leading to Perm Discontinuation | 7 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | TEAEs Leading to Death | 44 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Study Drug-Related TEAEs Leading to Death | 1 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Deaths | 47 participants |
| mITT - Aspergillus [Renally Impaired] | Safety - Overall Number of TEAEs | Deaths Through 28 Days after Last Dose Study Drug | 42 participants |