Ampholipad Real-World Data in Taiwan

Study Overview
=================
Brief Summary
-----------------
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.

Detailed Description
-----------------
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad in selected sentinel hospitals in Taiwan. Medical charts of approximately 100 treated patients will be reviewed by the investigators to collect the pre-specified data, including indication, underlying cancer type (only for cancer patients), demographics, and concomitant medications as well as all the laboratory examination data regarding renal function from 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course.

Official Title
-----------------
A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan

Conditions
-----------------
Aspergillus Infection, Febrile Neutropenia, Candida Infection, Fungal Infection, Cryptococcal Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 2 years of age Patients who had received at least one dose of Ampholipad treatment, with available baseline serum creatinine (SCr) data within 1 month prior to first Ampholipad use and at least one post baseline SCr data during treatment period Exclusion Criteria: Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only) Patients who had documented HIV infection diagnosis Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nephrotoxicity | Nephrotoxicity is defined as an increase in serum creatinine (SCr) to >2X baseline value and the post-baseline peak SCr > 1.2 mg/dL | Ampholipad treatment course, up to 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values | Incidence of SCr >1.5X, SCr >2X or SCr >3X of the baseline values | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | 
| Incidence of Adverse Drug Reaction (ADR) | Number of ADRs reported/collected during the protocol-defined retrospective medical chart review period | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | 
| eGFR | Changes in estimated glomerular filtration rate (eGFR) from baseline throughout the Ampholipad treatment period | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | 
| Survival rate | Survival rate through 7 days after the last day of the Ampholipad treatment | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | 
| Microbiological eradication rate | Microbiological eradication rate of Ampholipad treatment | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | 
| Fever resolution rate | Fever resolution rate of Ampholipad treatment in febrile neutropenic patients | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course |