Clinical trial NCT03641131: Ampholipad Real-World Data in Taiwan
Official title: A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspergillus Infection
Febrile Neutropenia
Candida Infection
Fungal Infection
Cryptococcal Infections
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had received at least one dose of Ampholipad treatment in Taiwan

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of nephrotoxicity
timeFrame: Ampholipad treatment course, up to 42 days
Secondary outcomes:
measure: Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
measure: Incidence of Adverse Drug Reaction (ADR)
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
measure: eGFR
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
measure: Survival rate
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
measure: Microbiological eradication rate
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
measure: Fever resolution rate
timeFrame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taipei
country: Taiwan
facility: Tri Service General Hospital
Study officials:
affiliation: Taiwan Liposome Company
name: Carl Brown, PhD
role: STUDY_DIRECTOR
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citation: White MH, Bowden RA, Sandler ES, Graham ML, Noskin GA, Wingard JR, Goldman M, van Burik JA, McCabe A, Lin JS, Gurwith M, Miller CB. Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia. Clin Infect Dis. 1998 Aug;27(2):296-302. doi: 10.1086/514672.
citation: Wingard JR, White MH, Anaissie E, Raffalli J, Goodman J, Arrieta A; L Amph/ABLC Collaborative Study Group. A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. L Amph/ABLC Collaborative Study Group. Clin Infect Dis. 2000 Nov;31(5):1155-63. doi: 10.1086/317451. Epub 2000 Nov 7.
citation: Walsh TJ, Finberg RW, Arndt C, Hiemenz J, Schwartz C, Bodensteiner D, Pappas P, Seibel N, Greenberg RN, Dummer S, Schuster M, Holcenberg JS. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group. N Engl J Med. 1999 Mar 11;340(10):764-71. doi: 10.1056/NEJM199903113401004.