Cryptococcal meningitis
Conditions
Interventions
2:0.5mg/kg/d amphotericin B +/- flucytosine
1:0.7mg/kg/d amphotericin B +/- flucytosine
3:800mg/d fluconazole +/- flucytosine
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) The patients aged >=18 years, with cryptococcal meningitis; 2) Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. HIV infected patients 2. Pregnant and lactating patients 3. Creatinine clearance rate is less than 50ml/d (The test will be completed within 3 days after enrollment) 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is more than 5 times of the normal upper limit or bilirubin is more than 2.5 times of the normal upper limit; 5. Patients known to be intolerant or allergic to fluconazole or amphotericin B; 6. The estimated survival rate is less than 2 weeks; 7. Coma patients; 8. Systemic antifungal therapy should not be more than 3 days, or other systemic antifungal therapy should be needed at the same time, except for patients who use antifungal drugs prophylactically; 9. Subjects who took rifampicin, rifamycin, rifampicin, phenytoin sodium, carbamazepine, cyclosporin A, tacrolimus, sirolimus or long-acting barbiturates within 7 days of study registration; 10. Patients who have previously participated in this study or are participating in another research drug trial; 11. Other circumstances, such as intravenous drug use, that may endanger the safety of the subjects participating in the study or make them unable to comply with the study plan, which is considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| early fungicidal activity;Intracranial pressure (ICP) monitoring within 2 weeks of treatment;The efficacy of 4 weeks and 10 weeks of treatment;Visual impairment at 10 weeks of treatment;Incidence of IRIS;Recurrence rate of cryptococcal meningitis;New neurological events occurred during 10 weeks of treatment;Mortality at 2 weeks and 1 year of treatment;Disability rate at 1 year of treatment; | — |
Countries
China
Contacts
Public ContactLi-Ping Zhu
Huashan Hospital, Fudan University
Outcome results
None listed