Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
120 participants
INTERVENTIONAL
2021-01-25
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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voriconazole treatment
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
Voriconazole 200mg
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
amphotericin treatment (0.7-1.0mg/kg/d)
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-deoxycholate (0.7-1.0mg/kg/d)
Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days
amphotericin B treatment (0.4-0.5mg/kg/d)
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
amphotericin B deoxycholate (0.4-0.5mg/kg/d)
Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
Interventions
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Voriconazole 200mg
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
amphotericin B deoxycholate (0.4-0.5mg/kg/d)
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)
Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
3. Anti-viral treatment naïve patients
4. anti-fungal treatment naïve patients
Exclusion Criteria
2. liver cirrhosis;
3. congestive heart failure;
4. chronic renal disorders;
5. chronic obstructive pulmonary disease (COPD);
6. Tuberculosis co-infection;
7. malignances
8. severe mental and neurological diseases
9. Women during pregnancy and lactation
10. intraveneous drug user (IDU)
11. patients with follow abnormal test results:hemoglobin \< 6 g/dl, white blood cell count \< 2000 / μl, neutrophil count \< 1000 / μl, platelet count \< 75000 / μl, blood amylase \> 3 times normal level Upper limit, serum creatinine \> 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase \> 3 times normal upper limit, total bilirubin \> 2 times normal upper limit
12. patients who are unwilling to anticipate.
18 Years
65 Years
ALL
No
Sponsors
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Wenzhou Central Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Lijun Xu, PH.D
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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Lijun Xu
Zhenjiang, Hangzhou, China
Countries
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Other Identifiers
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2018-014-1
Identifier Type: -
Identifier Source: org_study_id
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