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Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single drug group | Active Comparator | Liposomal amphotericin B (AmBisome®) |
|
| Combination therapy | Experimental | Liposomal amphotericin B (AmBisome®) combination with Isavuconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy group | Drug | Liposomal amphotericin B (AmBisome®) combination with Isavuconazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4-week favourable response rate | The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT. | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| 12-week mortality | Defined as the proportion of patients who died by 12 week. | 12 week |
| 24-week mortality | Defined as the proportion of patients who died by week 24. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Cao, M.D. | Contact | +010086 15210682464 | zhibo_liu1985@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Cao | China-Japan Friendship Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
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| Liposomal Amphotericin B | Drug | Liposomal amphotericin B (AmBisome®) alone |
|
| 24 week |
| Frequency of adverse events | Treatment-related adverse event frequency | 4 week |