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Due to administrative reasons
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To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Intravenous (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall success rate | success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment) | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse events | up to 10 weeks |
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Inclusion Criteria:
The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| 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 |
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| Changsha |
| China |
| Chengdu | China |
| Fuzhou | China |
| Guangzhou | China |
| Harbin | China |
| Hengyang | China |
| Jinan | China |
| Nanjing | China |
| Shanghai | China |
| Shaoyang | China |
| Shenyang | China |
| Tianjin | China |
| Xi'an | China |
| Xiamen | China |
| D000072742 |
| Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |