Invasive fungal disease
Conditions
Interventions
Experimental group:Intravenous ABCD
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 14 to 70 years, male or female; 2.Patients with hematological malignant tumors such as leukemia and lymphoma who received chemotherapy or hematopoietic stem cell transplantation; 3.Meet any of the following diagnostic criteria: (1)Experientially treated patients: neutropenia (absolute peripheral blood neutrophil count [ANC] = 38.3 ? (axillary temperature >= 38.0 ?) at least twice (time interval >= half an hour), or >= 38 ? (axillary temperature >= 37.7 ?) lasted for more than 1 hour. 5.After using broadspectrum antimicrobial therapy for at least 96 hours before screening, recurrent or persistent fever still appeared that fungal infection was suspected. 6.The expected survival time is >= 3 months; 7.The subjects voluntarily participated and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The patients did not receive adequate antibacterial treatment; 2.Allergic to amphotericin B drugs or cholesterol sulfate complex; 3.Two or more antifungal agents were used in the month before screening; 4.Invasive fungal infection confirmed or clinically diagnosed during screening period; 5.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 or AST >= 3 times of the ULN with 1.5 times increase of total bilirubin); 6.Patients with impaired renal function who need or are currently undergoing hemodialysis or peritoneal dialysis; 7.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; 8.Pregnant and lactating women; 9.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 |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of treatment;Duration of fever;Duration of febrile neutropenia;Completion rate of amphotericin B colloidal dispersions;Cost-effectiveness analysis; | — |
Countries
China
Contacts
Public ContactWu Depei
The First Affiliated Hospital of Soochow University
Outcome results
None listed