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This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin Sodium | Drug | micafungin sodium ≥ 100, <200mg/time, once a day, intravenous drip. Low dose group |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical efficacy | Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by lab-test and adverse events | Incidence of adverse reactions in different dose groups of micafungin | 30 days |
| Survival rate | IFD-related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xin wang, MD, PHD | Contact | 86-531-68778331 | xinw007@126.com | |
| changqing zhen, MD | Contact | 86-531-68778331 | zcq1521@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xin wang, MD, PHD | Shandong Provincial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Provincial Hospital Affiliated to Shandong University | Recruiting | Jinan | Shandong | 250021 | China |
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The patients will be randomized either low dose group or high dose group
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| 30 days |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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