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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: patients received L-AmB therapy | Dose: 3-5mg/kg/day administered intravenouly(IV). Duration of treatment: Researchers determine based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. All drug dosages are in accordance with the drug instructions.All treatments must be prescribed according to local routine clinical practice, and the preparation and administration of drugs must be carried out in accordance with the instructions and guidelines provided by the manufacturer. | ||
| Group 2: patients received isavuconazole/posaconzazole therapy | Foumulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300mg (posaconzazole) or 200mg (isavuconazole) once daily. Duration of treatment: Researchers determine based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. All drug dosages are in accordance with the drug instructions. All treatments must be prescribed according to local routine clinical practice, and the preparation and administration of drugs must be carried out in accordance with the instructions and guidelines provided by the manufacturer. |
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| Measure | Description | Time Frame |
|---|---|---|
| The favorable overall responses rate at the end of treatment (proportion of patients achieving complete or partial remission) | The end of treatment refers to the time when L-AmB or Isavuconazole/posaconazole treatment ends. According to the EORTC/MSG (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycosis Study Group)efficacy evaluation criteria based on clinical evaluation, the response is divided into complete remission, partial remission, disease stability, disease progression, and death directly related to the study drug or IFD(invasive fungal disease). Effective refers to complete and partial remission. | through study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate at key time points | proportion of participants alive at (1) end of treatment (2) 42 days post-therapy (3)84 days post-therapy. Survival is defined as being free from death due to any cause | through study completion, an average of 2 weeks |
| Time to favorable overall response |
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Inclusion Criteria:
Exclusion Criteria:
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breakthrough invasive fungal disease in patients with malignant hematological diseases after antifungal prophylaxis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie jiang, doctor | Contact | 02223608600 | jiangerlie@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 |
No plan to share IPD
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Non-Probability Sample
Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance) |
| 14 days |
| Length of hospitalization | Total number of days participants spend hospitalized from enrollment until discharge or death. | 30 days |
| incidence of treatment-emergent adverse events | incidence and severity of treatment-emergent adverse events(TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE V5.0(National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0) criteria. | 30 days |
| China |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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