Ampholipad Real-World Data in Taiwan
Study Details
Study Description
Brief Summary
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female ≥ 2 years of age
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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:
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Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only)
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Patients who had documented HIV infection diagnosis
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Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shuang Ho Hospital | New Taipei City | Taiwan | ||
| 2 | Chung Shan Medical University Hospital | Taichung | Taiwan | ||
| 3 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 4 | Chi Mei Hospital | Tainan | Taiwan | ||
| 5 | Taipei Municipal Wanfang Hospital | Taipei | Taiwan | ||
| 6 | Tri Service General Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Taiwan Liposome Company
Investigators
- Study Director: Carl Brown, PhD, Taiwan Liposome Company
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- TLC166B4013