invasive mildew
Conditions
Interventions
Experimental group:amphotericin B cholesterol sulfate complex for injection
Sponsors
The First Affiliated Hospital Of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Patients diagnosed as confirmed/probable/invasive mildew; 3. Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication; 4. Female subjects must meet one of the following conditions: surgical sterilization; menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment; 5. Signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Allergic to amphotericin B or cholesterol sulfate complex; 2. Systemic therapeutic doses of antifungal drugs were given for more than 5 days within 7 days before enrollment (except those who had received fluconazoleExcept prophylactic medication)or Accumulated doses of amphotericin deoxycholic acid exceeding 10 mg/kg were used within 10 days before enrollment or More than 15 mg/kg amphotericin lipid; 3. Patients with Invasive mildew that are insensitive to or resistant to amphotericin B treatment, such as patients with invasive Aspergillus terrautus and neste-building Aspergillus; 4. Patients with abnormal liver function; 5. Patients with reduced renal function requiring hemodialysis or peritoneal dialysis; 6. Patients with clinically significant hypokalemia (defined as serum potassium concentration< 3.2 mmol/L or undergoing digitalization with blood potassium below the lower limit of normal) and hypokalemia could not be corrected before trial treatment was initiated; 7. Patients who planned to use prohibited drugs during the study period; 8. Expected survival is less than 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infusion related adverse events, nephrotoxicity, hypokalemia, and liver damage occurred during treatment and follow-up period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who completed study drug treatment at 4 weeks or 6 weeks;Other adverse events, laboratory tests, electrocardiograms, vital signs, and routine physical examinations;The percentage of patients who completed the study's drug treatment period and are effective; | — |
Countries
China
Contacts
Public ContactYe Feng
Outcome results
None listed