Ampholipad Real-World Data in Taiwan

Taiwan Liposome Company102 enrolled

Overview

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Aspergillus Infection Febrile Neutropenia Candida Infection Fungal Infection Cryptococcal Infections

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female ≥ 2 years of age 2. 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: 1. Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only) 2. Patients who had documented HIV infection diagnosis 3. Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use

Locations (6)

Shuang Ho Hospital

New Taipei City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

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

Time frame: Ampholipad treatment course, up to 42 days