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A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever | Clinical Trials | Clareo Health

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A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever

NCT03511820•TTY Biopharm

View on ClinicalTrials.gov

Summary

Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal infections. It is associated with many side effects which in some cases can be very severe and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever in routine clinical practice in Taiwan. 1. Primary objective: • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic patients with persistent fever in Taiwan clinical practice. 2. Secondary objectives: (1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice. (2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients with persistent fever in Taiwan clinical practice.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Female or male with no age limit
•2. Patient for whom Lipo-AB® is medically recommended due to following conditions:
•* Absolute neutrophil count (ANC) \< 500/mm3 for at least 96 hours
•* Received parenteral broad spectrum antibacterial therapy for at least 96 hours
•* Fever of ≥ 38.0°C (tympanic temperature)
•3. Subject or his/her legally acceptable representative is willing and able to provide a written informed consent

Exclusion Criteria

•1. Pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved
•2. Use of other investigational product 2 weeks before the initiation of Lipo-AB® treatment which is considered not suitable for this study by investigator
•3. Use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response)
•4. Any condition which is considered not suitable for liposomal amphotericin B therapy by investigator

Locations (9)

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Taipei Mucinipal Wanfang Hospital

Taipei, Taiwan

Chang Guang Memorial Hospital at LinKou

Taoyuan District, Taiwan

Key Dates

Start Date

May 24, 2016

Primary Completion Date

January 15, 2018

Completion Date

January 15, 2018

Last Updated

April 30, 2018

Enrollment

ACTUAL participants

Conditions

Neutropenia, Febrile

Interventions

Lipo-AB® (amphotericin B) liposome

DRUG

Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

NCT03217721

Neutropenia, Febrile

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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