Aspergillus Infection, Candida Infection, Cryptococcal Infections, Febrile Neutropenia, Fungal Infection
Conditions
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.
Interventions
None listed
Sponsors
Taiwan Liposome Company
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nephrotoxicity | Ampholipad treatment course, up to 42 days | Nephrotoxicity is defined as an increase in serum creatinine (SCr) to \>2X baseline value and the post-baseline peak SCr \> 1.2 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Drug Reaction (ADR) | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | Number of ADRs reported/collected during the protocol-defined retrospective medical chart review period |
| eGFR | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | Changes in estimated glomerular filtration rate (eGFR) from baseline throughout the Ampholipad treatment period |
| Proportion 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 SCr \>1.5X, SCr \>2X or SCr \>3X of the baseline values |
| Microbiological eradication rate | 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 of Ampholipad treatment |
| Fever resolution rate | 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 of Ampholipad treatment in febrile neutropenic patients |
| Survival rate | From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course | Survival rate through 7 days after the last day of the Ampholipad treatment |
Countries
Taiwan
Outcome results
None listed