Overview
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.
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 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. The research objective of this study is to: 1. Evaluate efficacy: The main objective is to determine the therapeutic effect of L-AmB (liposomal amphotericin B) or Isavuconazole/posaconazole on breakthrough invasive fungal disease, including percentage of patients with favorable overall response, survival rate, median to fever remission time, length of hospital stay, etc.2. Evaluate safety: Study the safety of drugs, including monitoring and recording all adverse events, side effects, and drug-related toxicity. 3. Patient population analysis: Study the differences in response to treatment with liposomal amphotericin B and Isavuconazole/posaconazole among different patient populations (such as different ages, genders, and underlying disease states).
These research objectives will contribute to a comprehensive understanding of the roles of L-AmB and Isavuconazole/posaconazole in the treatment of breakthrough fungal infections, and provide scientific evidence for clinical practice.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.