Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases
The Efficacy and Safety of Liposomal Amphotericin B and Isavuconazole/Posaconazole in the Treatment of Breakthrough Invasive Fungal Disease in Patients With Malignant Hematological Diseases After Antifungal Prophylaxis
Institute of Hematology & Blood Diseases Hospital, China
36 participants
May 19, 2025
OBSERVATIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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.
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Locations(1)
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NCT07135778