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| Name | Class |
|---|---|
| Wenzhou Central Hospital | OTHER |
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Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.
HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3)14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| voriconazole treatment | Experimental | induction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
|
| amphotericin treatment (0.7-1.0mg/kg/d) | Active Comparator | Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
|
| amphotericin B treatment (0.4-0.5mg/kg/d) | Experimental | Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole 200mg | Drug | Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90-day Cryptococcal Meningitis (CM) related mortality | analysis of 90-day CM-related mortality of patients in three induction treatments | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Early fungicidal rate in Cerebrospinal fluid (CSF) | Comparison of 2-week CSF early fungicidal activity in three induction treatments | 2 weeks |
| creatinine elevation | TO observe the numbers of patients whose creatinine > 110 mmol/L during antifungal therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lijun Xu, PH.D | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lijun Xu | Zhenjiang | Hangzhou | 310020 | China |
12 months after study finished
12 months
Qualified researchers may submit a request containing the research objectives, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| C059765 | amphotericin B, deoxycholate drug combination |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| amphotericin B deoxycholate (0.4-0.5mg/kg/d) | Drug | Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days |
|
|
| Amphotericin B-deoxycholate (0.7-1.0mg/kg/d) | Drug | Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days |
|
|
| 0-90 days |
| Hypokalemia | To observe the rate of hypokalemia in three groups during antifungal therapy | 0-90 days |
| anemia | Comparison of the numbers of patients with hemoglobin <120g/L for male or <110g/L for female. | 0-90 days |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |