Ampholipad Real-World Data in Taiwan

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641131
• Other study ID #: TLC166B4013
• Status: Completed
• Start date: September 9, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2021
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 8, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Aspergillus Infection
• Candida Infection
• Candidiasis
• Communicable Diseases
• Cryptococcal Infections
• Febrile Neutropenia
• Fungal Infection
• Infection
• Mycoses
• Neutropenia

Locations

Country	Name	City	State
Taiwan	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	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Tri Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073. — View Citation

Girois SB, Chapuis F, Decullier E, Revol BG. Adverse effects of antifungal therapies in invasive fungal infections: review and meta-analysis. Eur J Clin Microbiol Infect Dis. 2005 Feb;24(2):119-30. Review. Corrected and republished in: Eur J Clin Microbiol Infect Dis. 2006 Feb;25(2):138-49. — View Citation

Laniado-Laborín R, Cabrales-Vargas MN. Amphotericin B: side effects and toxicity. Rev Iberoam Micol. 2009 Dec 31;26(4):223-7. doi: 10.1016/j.riam.2009.06.003. Review. — View 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. — View 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. — View 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. Epub 2000 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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