invasive fungal disease
Conditions
Interventions
Experimental group:Use amphotericin B cholesterol sulfate complex for injection
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-70 years; 2. Patients with hematological diseases who plan to undergo allogeneic hematopoietic stem cell transplantation; 3. Have a history of confirmed or clinically diagnosed IFD within 6 months before transplantation, and achieve complete or partial remission or stability (according to relevant standards in Diagnostic Criteria and Treatment Principles for Invasive Mycosis in Patients with Hematologic Malignancies (Sixth Revision)); 4. ECOG score is 0-2; 5. Patients voluntarily participated in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to amphotericin B or cholesterol sulfate complex; Patients with contraindication of amphotericin B cholesterol sulfate complex for injection; 2. There is any absolute contraindication of allogeneic hematopoietic stem cell transplantation; 3. Active tuberculosis patients, HIV positive patients; 4. There are other uncontrolled serious active infections, such as EB virus active infection, CMV pneumonia, etc; 5. There are other serious diseases so that the expected survival period is less than 3 months; 6. Heart disease: including echocardiography EF 2 x UNL (upper limit of normal value); Renal function: blood creatinine > 1.5 x UNL or creatinine clearance rate<60 mL/min; 9. Pregnant or lactating patients, women of childbearing age who refused to take effective contraceptive measures during the study period; 10. Have a history of serious neurological or psychiatric diseases, including dementia or epilepsy; Or drug abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence rate of breakthrough fungal infection and recurrence rate of original fungal infection within 7 days after starting the trial drug treatment and stopping the drug; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety from the beginning of the trial drug treatment to the 7th day after the drug withdrawal: adverse reactions, treatment related mortality, and other infection rates (bacteria, viruses); Safety/toxicity monitoring of pretreatment related toxicity;Hematopoietic reconstruction: including neutrophil implantation time, platelet implantation time and implantation rate;Severity and incidence of acute and chronic GVHD after transplantation;Incidence of other infections within 1 year after transplantation: the incidence of CMV, EBV reactivation, CMV disease, EBV related PTLD, and bacterial infection;Cumulative recurrence rate within 1 year after transplantation;Non recurrence survival within 1 year after transplantation;Total survival time of 1 year after transplantation;Non recurrent mortality at 1 year after transplantation;One year optimized GVHD free relapse free survival;Quality of life score 1 year after transplantation; | — |
Countries
China
Contacts
Public ContactWu Yuanbin
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed