Invasive fungal disease
Conditions
Interventions
trial group:ABCD for intravenous
Sponsors
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female; 2. Acute leukemia confirmed by bone marrow cytology, histochemistry and immunology; 3. Invasive aspergillosis after chemotherapy (including induction, consolidation, and relapsing/refractory reinduction) or hematopoietic stem cell transplantation; 4. According to the Revised Definition of Invasive fungal diseases, and meeting the EORTC-MSG diagnostic criteria, the patients with proven/probable/possible invasive fungal diseases; 5. Patients who the investigator believes would benefit clinically from participating in the study; 6. Patients participated in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who were previously treated with intravenous polyene antifungal drugs; 2. Allergic to amphotericin B or cholesterol sulfate complex; 3. Patients with abnormal liver function (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 5 times the upper limit of normal value (ULN) without increase of total bilirubin, or ALT/AST >= 3 times of the ULN with 1.5 times increase of total bilirubin; 4. Patients with impaired renal function (blood creatinine (Cr) is more than 2 times higher than the upper limit of normal (ULN), or 24-hour urine creatinine clearance rate Ccr is less than 50ml/min), or patients who need or are currently undergoing hemodialysis or peritoneal dialysis; 5.Clinically significant hypokalemia (defined as serum potassium concentration < 3.2 mmol/L, or in digitalis patients whose serum potassium is lower than the lower limit of normal value), and hypokalemia cannot be corrected before starting trial treatment; 6. Pregnant women, breast-feeding women, and women of childbearing age who refused to take effective contraceptive measures during the study period; 7. The researchers believe that it is not suitable to participate in this trial, such as severe organ dysfunction, clinically significant laboratory abnormalities, understanding or compliance problems, and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events during treatment;Median time to nephrotoxicity and hypokalemia;Proportion of patients with continuous pretreatment of dexamethasone for less than 3 days; | — |
Countries
China
Contacts
Public ContactFeng Sizhou
Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed