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The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.
The main questions it aims to answer are:
This is a single-arm, prospective study. Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphotericin B Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericin B | Drug | Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days) | The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease. | 6 weeks (42 days) after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate at 6 Weeks | Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy. | 6 weeks (42 days) after treatment initiation |
| Change in serum G test level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Ma | Contact | +86 18834948122 | marui_pku_ed@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Change from baseline in serum (1,3)-β-D-glucan level. Unit of measure: pg/mL.
| From enrollment to the end of 6-week treatment |
| Change in serum GM test level | Change from baseline in serum galactomannan test value. Unit of measure: ug/L. | From enrollment to the end of 6-week treatment |
| Microbiological clearance | Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture). | From enrollment to the end of 6-week treatment |
| Change in chest CT findings | Change from baseline in chest CT lesion characteristics (e.g., reduction in size, new lesions, complete resolution). | Baseline to 6 weeks after treatment initiation |
| Proportion of participants with treatment-emergent adverse events (AEs) | Proportion of participants experiencing any AE, graded according to WHO toxicity criteria (grade 3 or higher AEs leading to drug discontinuation). | From first dose to 30 days after last dose. |
| Proportion of participants discontinuing amphotericin B due to adverse events | Proportion of participants who permanently stop amphotericin B because of any AE. | During treatment period (up to 6 weeks). |
| Change in serum alanine aminotransferase (ALT) | Change from baseline in ALT level. Unit of measure: U/L. | Baseline to end of treatment up to 6 weeks (twice weekly). |
| Change in serum aspartate aminotransferase (AST) | Change from baseline in AST level. Unit of measure: U/L. | Baseline to end of treatment up to 6 weeks (twice weekly). |
| Change in serum total bilirubin | Change from baseline in total bilirubin level. Unit of measure: μmol/L. | Baseline to end of treatment up to 6 weeks (twice weekly). |
| Change in serum creatinine | Description: Change from baseline in serum creatinine level. Unit of measure: μmol/L. | Baseline to end of treatment up to 6 weeks (twice weekly). |
| Change in serum electrolyte levels (potassium, sodium, calcium, magnesium) | Change from baseline in serum levels of potassium, sodium, calcium, and magnesium. Each electrolyte will be reported separately as absolute change (mmol/L) from baseline. | Baseline to end of treatment up to 6 weeks (twice weekly). |
| Change in electrocardiogram (ECG) findings | Change from baseline in ECG parameters (e.g., QTc interval). | Baseline to end of treatment up to 6 weeks (weekly). |