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Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal infections. It is associated with many side effects which in some cases can be very severe and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever in routine clinical practice in Taiwan.
Primary objective:
• To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice.
Secondary objectives:
(1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.
(2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipo-AB® (amphotericin B) liposome | Drug |
All patients will receive Lipo-AB® based on the approved package insert and physician's clinical decision. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of nephrotoxicity | * Nephrotoxicity is defined as serum creatinine (SCr) values increasing 100% or more over pretreatment levels in pediatric patients, and creatinine values increasing 100% or more over pretreatment levels in adult patients provided the peak creatinine concentration was > 1.2 mg/dL during treatment period. ** The nephrotoxicity associated with baseline SCr will also be assessed. | through Observation period (up to 44 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Categorization of the change in renal function |
| through Observation period (up to 44 days) |
| Change in laboratory parameters (1) |
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Inclusion Criteria:
Female or male with no age limit
Patient for whom Lipo-AB® is medically recommended due to following conditions:
Subject or his/her legally acceptable representative is willing and able to provide a written informed consent
Exclusion Criteria:
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Neutropenic patients with persistent fever who are recommended to receive systemic antifungal therapy based on physician's decision will be invited to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | 500 | Taiwan | |||
| Kaohsiung Veterans General Hospital |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| D008081 | Liposomes |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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hemoglobin (Hb in g/dL)
| through Observation period (up to 44 days) |
| Change in laboratory parameters (2) | hematocrit (Hct in %) | through Observation period (up to 44 days) |
| Change in laboratory parameters (3) | red blood cell (RBC in 10^6/uL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (4) | white blood cell (WBC in 10^3/uL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (5) | ANC (absolute neutrophil count in mm^3) | through Observation period (up to 44 days) |
| Change in laboratory parameters (6) | platelet count in 10^3/uL | through Observation period (up to 44 days) |
| Change in laboratory parameters (7) | alanine aminotransferase (ALT in U/L) | through Observation period (up to 44 days) |
| Change in laboratory parameters (8) | aspartate aminotransferase (AST in U/L) | through Observation period (up to 44 days) |
| Change in laboratory parameters (9) | total bilirubin (TB in mg/dL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (10) | BUN in mg/dL | through Observation period (up to 44 days) |
| Change in laboratory parameters (11) | serum creatinine (SCr in mg/dL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (12) | glucose (mg/dL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (13) | Na (mmol/L) | through Observation period (up to 44 days) |
| Change in laboratory parameters (14) | K (mmol/L) | through Observation period (up to 44 days) |
| Change in laboratory parameters (15) | Mg (mg/dL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (16) | Ca (mg/dL) | through Observation period (up to 44 days) |
| Change in laboratory parameters (17) | Urine protein (mg/dL) | through Observation period (up to 44 days) |
| Change in vital signs (1) | systolic/diastolic blood pressure (SBP/ DBP in mmHg) | through Observation period (up to 44 days) |
| Change in vital signs (2) | pulse rate (PR in bpm) | through Observation period (up to 44 days) |
| Change in vital signs (3) | tympanic temperature (TT in °C) | through Observation period (up to 44 days) |
| Adverse event(s) | Hypokalemia, Hypomagnesemia, Hypocalcemia, Hypernatremia, Hyponatremia, Infusion-related reaction(s) (IRR), Other adverse event(s). | through Observation period (up to 44 days) |
| Overall success rate | Defined as a composite of five criteria:
| through Observation period (up to 44 days) |
| Overall survival rate | through Observation period (up to 44 days) |
| Kaohsiung City |
| 81362 |
| Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| Keelung Chang Gung Memorial Hospital | Keelung | 204 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11212 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Taipei Mucinipal Wanfang Hospital | Taipei | 116 | Taiwan |
| Chang Guang Memorial Hospital at LinKou | Taoyuan | 333 | Taiwan |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D008567 |
| Membranes, Artificial |
| D001697 | Biomedical and Dental Materials |
| D004337 | Drug Carriers |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D040761 | Biomimetic Materials |