Fungal disease
Conditions
Interventions
Only one drug group:Posaconazole oral suspension
Drug combination group:Posaconazole suspension in combination with other drugs
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients older than 13 years (inclusive) 2. Patients with hematologic malignancies (hematologic malignancies) receiving chemotherapy (hematologic diseases include aplastic anemia, acute myeloid leukemia, acute lymphoblastic leukemia, non-lymphoma, multiple myeloma, etc.); Patients expected to receive chemotherapy who have had persistent or at least 7 days of persistent neutropenia (absolute neutrophils less than 0.5 x 10^9) will be treated with posaconazole to prevent fungal infection; 3. Patients or its legal guardian will sign the informed consent in person. or its legal guardian will sign the informed consent in person.
Exclusion criteria
Exclusion criteria: 1. Severe diseases of other organs except blood diseases, such as abnormal cardiovascular and nervous system; Or there may be unstable during the study period or progressive damage (such as a seizure or nerve demyelination syndrome, rounding out the top three months had acute myocardial infarction, myocardial ischemia, congestive heart failure, heart quiver with heart rate < 60 / min, or a history of cutting-edge reverse type of ventricular tachycardia, symptomatic ventricular or persistent arrhythmia), electrolyte disorder; 2. Have used other research drugs or biological products or participated in other clinical trials within 30 days before inclusion; 3. Known or suspected allergy or specific reaction to azole or amphotericin B; 4. Specific or suspected IFD has been found during screening; 5. Severe renal insufficiency (creatinine clearance < 50mL/min, or dialysis may be required during the trial), or ALT, AST, alkaline phosphatase, or total bilirubin greater than 2 times the upper limit of normal (ULN); 6. A history of allogeneic stem cell transplantation, or bone marrow transplantation, or autologous stem cell transplantation; 7. Pregnant or lactating women; 8. A history of alcohol and/or drug abuse; 9. No collaborators judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function;Renal function; | — |
Countries
China
Contacts
Public ContactYu Jing
The First Hospital of Hebei Medical University
Outcome results
None listed