Actively Recruiting
Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD( Breakthrough Invasive Fungal Disease) in Patients With Malignant Hematological Diseases
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-22
36
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open label, controlled, single center real-world observational study. Adult (aged ≥ 18 years) patients with hematological malignancies develop breakthrough invasive fungal disease after receiving ≥ 7 days of echinocandin or triazole antifungal prophylaxis receive treatment with liposomal amphotericin B or treatment with Isavuconazole or posaconazole according to the clinical doctor's decision. It is planed to collect 36 patients receiving treatment with liposomal amphotericin B and 36 patients receiving treatment with Isavuconazole or posaconazole, and observe their efficacy and safety.
CONDITIONS
Official Title
Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD( Breakthrough Invasive Fungal Disease) in Patients With Malignant Hematological Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years at the beginning of treatment
- Able to understand and sign informed consent before starting the study
- Diagnosed with blood cancers such as Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
- Developed breakthrough invasive fungal disease after 7 days of triazole antifungal prophylaxis
- Breakthrough invasive fungal disease defined as any fungal infection during antifungal drug exposure
- Proven, probable, or possible invasive fungal disease according to Chinese guidelines for hematological disorders and cancers
You will not qualify if you...
- Allergies, rapid severe allergic reactions, or intolerance to liposomal amphotericin B or isavuconazole/posaconazole
- Serum creatinine level at least twice the upper limit of normal
- Liver enzyme levels (transaminase or alkaline phosphatase) at least five times the upper limit of normal, or bilirubin at least three times the upper limit
- Currently breastfeeding
- Pregnant
- Expected life expectancy less than 30 days
- Deemed ineligible by investigator for medical, ethical, or logistical reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
E
erlie jiang, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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