Aspergillus InfectionNCT03641131
Ampholipad Real-World Data in Taiwan
An observational study of Aspergillus Infection and Febrile Neutropenia, run by Taiwan Liposome Company at 6 sites in Taiwan.
Trial summary
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Aspergillus Infection, Febrile Neutropenia, Candida Infection
- How many people
- 102 participants
- Where
- 6 sitesTaiwan
- Study dates
- 9 Sep 2018to 8 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had received at least one dose of Ampholipad treatment in Taiwan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Shuang Ho Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi Mei Hospital
Tainan
Taipei Municipal Wanfang Hospital
Taipei
Tri Service General Hospital
Taipei
About this study
Official title: A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.
Read the 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.
- Conditions
- Aspergillus Infection, Febrile Neutropenia, Candida Infection, Fungal Infection, Cryptococcal Infections
- Medical subject headings
- Aspergillosis, Febrile Neutropenia, Candidiasis, Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ampholipad treatment course, up to 42 days
Secondary outcomes (6)
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
Measured: 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)
Number of ADRs reported/collected during the protocol-defined retrospective medical chart review period
Measured: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
eGFR
Changes in estimated glomerular filtration rate (eGFR) from baseline throughout the Ampholipad treatment period
Measured: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Survival rate
Survival rate through 7 days after the last day of the Ampholipad treatment
Measured: 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
Microbiological eradication rate of Ampholipad treatment
Measured: 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
Fever resolution rate of Ampholipad treatment in febrile neutropenic patients
Measured: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start9 Sep 2018
- Primary completion2 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aspergillus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641131
- Sponsor's protocol ID
- TLC166B4013
- Status last verified
- Jan 2021
- First submitted
- 14 Aug 2018
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15711785Laniado-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.
PubMed 19836985Freifeld 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.
PubMed 21258094White 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.
PubMed 9709879Wingard 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.
PubMed 11073745Walsh 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.
PubMed 10072411
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan
- ClinicalTrials.gov ID
- NCT03641131
- Acronym / sponsor ID
- TLC166B4013
- Conditions
- Aspergillus Infection, Febrile Neutropenia, Candida Infection, Fungal Infection, Cryptococcal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had received at least one dose of Ampholipad treatment in Taiwan
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of nephrotoxicity
Time frame: 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
6 secondary outcomes
Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values
Time frame: 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)
Time frame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
eGFR
Time frame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Survival rate
Time frame: 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
Time frame: 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
Time frame: From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 15711785Girois 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.
- Background: PubMed 19836985Laniado-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.
- Background: PubMed 21258094Freifeld 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.
- Background: PubMed 9709879White 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.
- Background: PubMed 11073745Wingard 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.
- Background: PubMed 10072411Walsh 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.
Related trials for Aspergillus Infection
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Invasive Mold Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspergillus Infection and Febrile Neutropenia, run by Taiwan Liposome Company at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nephrotoxicity (time frame: Ampholipad treatment course, up to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641131, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.