Ampholipad Real-World Data in Taiwan

NCT03641131 | Completed

• 1 other identifier: TLC166B4013
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Aspergillus Infection; Febrile Neutropenia; Candida Infection; Fungal Infection; Cryptococcal Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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

• eGFR

  From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course

• Survival 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

  From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had received at least one dose of Ampholipad treatment in Taiwan

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (6)

Shuang Ho Hospital

New Taipei City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Chi Mei Hospital

Tainan, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

Tri Service General Hospital

Taipei, Taiwan

Location

Related Publications (6)

• 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. doi: 10.1007/s10096-005-1281-2.

  PMID: 15711785 BACKGROUND

• Laniado-Laborin 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.

  PMID: 19836985 BACKGROUND

• 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.

  PMID: 21258094 BACKGROUND

• 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.

  PMID: 9709879 BACKGROUND

• 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.

  PMID: 11073745 BACKGROUND

• 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.

  PMID: 10072411 BACKGROUND

MeSH Terms

Conditions

Aspergillosis; Febrile Neutropenia; Candidiasis; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: September 9, 2018
• Primary Completion: January 2, 2019
• Study Completion: January 8, 2019
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

TW (6)