Status:
RECRUITING
Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Invasive Fungal Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 disea...
Detailed Description
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 disea...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥ 18 years at the beginning of treatment.
- The patient or their guardian must be able to understand and sign a written informed consent form (which must be obtained before starting any research procedure)
- Blood based diseases, mainly AML( Acute Myeloid Leukemia), ALL(Acute Lymphoblastic Leukemia), MDS(Myelodysplastic Syndromes)
- Breakthrough invasive fungal disease occurs after receiving antifungal prophylaxis with triazole drugs for ≥ 7 days
- According to the latest definition of MSGERC, breakthrough IFD is defined as any IFD that occurs during exposure to antifungal drugs, including fungal infections outside the spectrum of antifungal activity
- Proven, probable, and possible IFD in accordance with the\< The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) \>
Exclusion
- Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to L-AmB or isavuconazole /posaconazole
- Serum creatinine level ≥ 2 times the upper limit of normal
- The level of transaminase or alkaline phosphatase is ≥ 5 times the normal upper limit, and bilirubin is ≥ 3 times the normal upper limit
- Patients who are breastfeeding
- Pregnant patients
- Expected life expectancy is less than 30 days
- Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07135778
Start Date
May 19 2025
End Date
December 31 2026
Last Update
August 22 2025
Active Locations (1)
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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