Invasive fungal disease
Conditions
Interventions
Experimental group:Intravenous ABCD
Sponsors
Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, no gender limitation; 2. According to the Revised Definition of Invasive fungal diseases, and meeting the EORTC-MSG diagnostic criteria, the patients with invasive fungal diseases were proven/probable/possible IFD; 3. Ineffective or intolerant treatment with other antifungal drugs before screening; 4. The inestigators determined that the patient could tolerate ABCD for at least 5 consecutive days; 5. Treatment with ABCD for injection was considered beneficial; 6. The subjects voluntarily participated in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects have not received other antifungal drugs before screening; 2. Allergic to amphotericin B or research pharmaceutical excipients; 3. Patients with abnormal liver function [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 5 times the upper limit of normal value (ULN) without total bilirubin elevation, or ALT or AST elevation 3 times the upper limit of normal value with total bilirubin elevation 1.5 times]; 4.Patients with renal dysfunction or who are currently undergoing hemodialysis or peritoneal dialysis; 5.In addition to the underlying diseases causing the fungal infection, there are unstable medical conditions, which are expected to be unstable or progress in the research process; 6. Conditions considered unsuitable for the study by the investigator, such as severe organ dysfunction, clinically significant laboratory abnormalities, understanding or compliance problems, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of nephrotoxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of drug-related adverse events (except nephrotoxicity);Median time to nephrotoxicity;Percentage of patients who discontinued treatment due to toxicity intolerance;Median time of therapy with study drug;A population pharmacokinetic model was established to evaluate the steady-state peak and trough concentrations, and the correlation between AUC and renal toxicity based on population pharmacokinetic model parameters; | — |
Countries
China
Contacts
Public ContactGe Weihong
Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Outcome results
None listed