A Phase 4 interventional study of Isavuconazole in Invasive Fungal Disease, sponsored by Pfizer. Completed at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting.
This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM).
The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.
146 studies on the registry are indexed under Invasive Fungal Infections; 35 are open to participants now.
This study's enrollment of 70 is below the median of 84 across 74 interventional studies indexed under Invasive Fungal Infections.
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Exclusion Criteria:
This is a single arm study, all enrolled participants will receive the study medication.
Drug: Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.
Also known as: Cresemba®
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
All-cause Mortality Rate Through Day 42
All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
Time frame: After first dose of study intervention (Day 1) through Day 42
All-cause Mortality Rate Through Day 84
All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
Time frame: After first dose of study intervention (Day 1) through Day 84
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(\>=) 90 percent (%)improvement from screening,2)\>= 50% to less than(\<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 180)
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) \>= 90 percent (%)improvement from screening, 2)\>= 50% to \< 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points. Clinical success rate: percentage of participants with clinical success at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before or at Day 84)
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 180). Success rate: percentage of participants with successful radiological response at specified time points.
Time frame: Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 84). Success rate: percentage of participants with successful radiological response at specified time points.
Time frame: Day 42, Day 84 and EOT (any day before Day 84)
Number of Participants With Treatment Related TEAEs
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. Treatment related TEAEs were TEAEs related to study intervention. AEs included both serious and all non-SAEs.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Study Intervention Discontinuation
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Death
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Death
Number of participants with death due to any cause were reported in this outcome measure.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Laboratory Test Abnormalities
Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of \<0.8\* lower limit of normal (LLN), erythrocytes \<0.8\* LLN, platelets \<0.5\* LLN \>1.75\* upper limit of normal (ULN), leukocytes \< 0.6\* LLN and \> 1.5\* ULN, lymphocytes and neutrophils \< 0.8\* LLN and \> 1.2\* ULN. b) Chemistry: bilirubin and direct bilirubin \>1.5\* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase \>3.0\* ULN, urea nitrogen, urea and creatinine \>1.3\* ULN, sodium \<0.95\* LLN and potassium\<0.9\* LLN. c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase \>= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
Predefined ECG criteria of clinical significance: a) heart rate (beats per minute \[bpm\]): value \<40 and value \>120; b) PR interval (millisecond \[(msec)\]: value\>280; c) QRS interval (msec): value\>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value \>500 and new prolongation value \>480 or increase \>= 60. Only those pre-defined ECG categories for which non-zero data were available have been reported below.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Abnormal Eye Examination
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
Time frame: Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)
| Milestone | Isavuconazole |
|---|---|
| Started | 70 |
| Completed | 51 |
| Not completed | 19 |
| Withdrew: Death | 13 |
| Withdrew: Withdrawal by subject | 6 |
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 55 | 9 |
All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
| Percentage of participants | Isavuconazole |
|---|---|
| All-cause Mortality Rate Through Day 42 | 14.3 (7.069 to 24.707) |
All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths \[actual\] and unknown deaths \[not actual but treated as deaths\]) among the overall number of participants analyzed.
| Percentage of participants | Isavuconazole |
|---|---|
| All-cause Mortality Rate Through Day 84 | 28.6 (18.405 to 40.622) |
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(\>=) 90 percent (%)improvement from screening,2)\>= 50% to less than(\<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 62.7 (48.080 to 75.874) |
| Day 84 | 56.9 (42.245 to 70.655) |
| EOT | 60.8 (46.114 to 74.156) |
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) \>= 90 percent (%)improvement from screening, 2)\>= 50% to \< 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)\>=25% to \<50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 61.9 (45.637 to 76.428) |
| Day 84 | 57.1 (40.961 to 72.279) |
| EOT | 61.9 (45.637 to 76.428) |
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 73.5 (58.918 to 85.053) |
| Day 84 | 66 (51.235 to 78.795) |
| EOT | 69.4 (54.585 to 81.748) |
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points. Clinical success rate: percentage of participants with clinical success at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 72.5 (56.112 to 85.399) |
| Day 84 | 65.9 (49.405 to 79.917) |
| EOT | 72.5 (56.112 to 85.399) |
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 72 (57.509 to 83.769) |
| Day 84 | 64.7 (50.068 to 77.569) |
| EOT | 68 (53.301 to 80.480) |
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 70.7 (54.463 to 83.870) |
| Day 84 | 64.3 (48.026 to 78.449) |
| EOT | 70.7 (54.463 to 83.870) |
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 180). Success rate: percentage of participants with successful radiological response at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 66 (51.235 to 78.795) |
| Day 84 | 60 (45.179 to 73.592) |
| EOT | 64 (49.193 to 77.084) |
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) \>=90% improvement from screening, (2) \>=50% to \<90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) \>=25% to \<50% improvement from screening for Day 42 and EOT (that is before Day 84). Success rate: percentage of participants with successful radiological response at specified time points.
| Percentage of participants | Isavuconazole |
|---|---|
| Day 42 | 66.7 (50.451 to 80.433) |
| Day 84 | 61.9 (45.637 to 76.428) |
| EOT | 66.7 (50.451 to 80.433) |
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. Treatment related TEAEs were TEAEs related to study intervention. AEs included both serious and all non-SAEs.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Treatment Related TEAEs | 23 | 9 |
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 19 | 3 |
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With TEAEs Leading to Study Intervention Discontinuation | 4 | 0 |
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With TEAEs Leading to Death | 9 | 2 |
Number of participants with death due to any cause were reported in this outcome measure.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Death | 11 | 2 |
Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of \<0.8\* lower limit of normal (LLN), erythrocytes \<0.8\* LLN, platelets \<0.5\* LLN \>1.75\* upper limit of normal (ULN), leukocytes \< 0.6\* LLN and \> 1.5\* ULN, lymphocytes and neutrophils \< 0.8\* LLN and \> 1.2\* ULN. b) Chemistry: bilirubin and direct bilirubin \>1.5\* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase \>3.0\* ULN, urea nitrogen, urea and creatinine \>1.3\* ULN, sodium \<0.95\* LLN and potassium\<0.9\* LLN. c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase \>= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Laboratory Test Abnormalities | 60 | 8 |
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | 0 | 0 |
Predefined ECG criteria of clinical significance: a) heart rate (beats per minute \[bpm\]): value \<40 and value \>120; b) PR interval (millisecond \[(msec)\]: value\>280; c) QRS interval (msec): value\>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value \>500 and new prolongation value \>480 or increase \>= 60. Only those pre-defined ECG categories for which non-zero data were available have been reported below.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Heart rate: value>120 beats/min | 2 | 0 |
| QRS interval: value>120 msec | 5 | 0 |
| QTCF: value>480 or Increase >= 60 msec | 2 | 0 |
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
| Participants | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| Number of Participants With Abnormal Eye Examination | 3 | 1 |
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
| Nanogram per milliliter (ng/mL) | Isavuconazole |
|---|---|
| Day 3: 0 hour | 3920 ± 1658.7 |
| Day 3: 1.5 hours post -dose | 5076 ± 2476.7 |
| Day 7: 0 hour | 4715 ± 1773.2 |
| Day 7: 1.5 hours post -dose | 5394 ± 1968.9 |
| Day 7: 3 hours post -dose | 5824 ± 1891.2 |
| Day 7: 6 hours post -dose | 5357 ± 1934.9 |
| Day 7: 12 hours post -dose | 4988 ± 1936.5 |
| Day 7: 24 hours post -dose | 4938 ± 2158.7 |
| Day 14: 0 hour | 5957 ± 2003.3 |
| Day 14: 1.5 hours post -dose | 6543 ± 2081.5 |
| Day 14: 3 hours post -dose | 7281 ± 2179.9 |
| Day 14: 6 hours post -dose | 6498 ± 2522.5 |
| Day 14: 12 hours post -dose | 5946 ± 1964.6 |
| Day 14: 24 hours post -dose | 5448 ± 1917.6 |
| EOT: 0 hours | 7224 ± 3665.2 |
| EOT: 24 hours (post -dose) | 6671 ± 2802.9 |
Collected over From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Invasive Aspergillosis + Other | 11/61 (18%) | 19/61 (31.1%) | 50/61 (82%) |
| Invasive Mucormycosis | 2/9 (22.2%) | 3/9 (33.3%) | 9/9 (100%) |
| Event | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| PneumoniaInfections and infestations | 3/61 | 2/9 |
| MyelosuppressionBlood and lymphatic system disorders | 0/61 | 1/9 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/61 | 1/9 |
| SepsisInfections and infestations | 1/61 | 1/9 |
| Septic shockInfections and infestations | 0/61 | 1/9 |
| Chronic kidney diseaseRenal and urinary disorders | 0/61 | 1/9 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/61 | 1/9 |
| Suspected drug-induced liver injuryHepatobiliary disorders | 2/61 | 0/9 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/61 | 0/9 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/61 | 0/9 |
| Event | Invasive Aspergillosis + Other | Invasive Mucormycosis |
|---|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 13/61 | 5/9 |
| AnaemiaBlood and lymphatic system disorders | 12/61 | 4/9 |
| HypoproteinaemiaMetabolism and nutrition disorders | 8/61 | 4/9 |
| PyrexiaGeneral disorders | 10/61 | 3/9 |
| COVID-19Infections and infestations | 0/61 | 3/9 |
| Gamma-glutamyltransferase increasedInvestigations | 10/61 | 3/9 |
| LeukopeniaBlood and lymphatic system disorders | 1/61 | 2/9 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/61 | 2/9 |
| Chest painGeneral disorders | 0/61 | 2/9 |
| Hepatic function abnormalHepatobiliary disorders | 4/61 | 2/9 |
Safety population consisted of all enrolled participants who received at least 1 dose of study intervention.
| Age, Continuous(Years) | Isavuconazole |
|---|---|
| Mean | 60 ± 14.02 |
| Sex: Female, Male(Participants) | Isavuconazole |
|---|---|
| Female | 22 |
| Male | 48 |
| Ethnicity (NIH/OMB)(Participants) | Isavuconazole |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 70 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Isavuconazole |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 70 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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