A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 9
- Primary Endpoint
- Incidence rate of nephrotoxicity
Study Overview
Brief 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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female or male with no age limit
- •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)
- •Subject or his/her legally acceptable representative is willing and able to provide a written informed consent
Exclusion Criteria
- •Pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved
- •Use of other investigational product 2 weeks before the initiation of Lipo-AB® treatment which is considered not suitable for this study by investigator
- •Use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response)
- •Any condition which is considered not suitable for liposomal amphotericin B therapy by investigator
Outcomes
Primary Outcomes
Incidence rate of nephrotoxicity
Time Frame: through Observation period (up to 44 days)
\* Nephrotoxicity is defined as serum creatinine (SCr) values increasing 100% or more over pretreatment levels in pediatric patients, and creatinine values increasing 100% or more over pretreatment levels in adult patients provided the peak creatinine concentration was \> 1.2 mg/dL during treatment period. \*\* The nephrotoxicity associated with baseline SCr will also be assessed.
Secondary Outcomes
- Change in laboratory parameters (1)(through Observation period (up to 44 days))
- Change in laboratory parameters (5)(through Observation period (up to 44 days))
- Change in laboratory parameters (8)(through Observation period (up to 44 days))
- Change in laboratory parameters (9)(through Observation period (up to 44 days))
- Categorization of the change in renal function(through Observation period (up to 44 days))
- Change in laboratory parameters (2)(through Observation period (up to 44 days))
- Change in laboratory parameters (3)(through Observation period (up to 44 days))
- Change in laboratory parameters (4)(through Observation period (up to 44 days))
- Change in laboratory parameters (7)(through Observation period (up to 44 days))
- Change in laboratory parameters (12)(through Observation period (up to 44 days))
- Change in laboratory parameters (6)(through Observation period (up to 44 days))
- Change in laboratory parameters (17)(through Observation period (up to 44 days))
- Change in vital signs (3)(through Observation period (up to 44 days))
- Adverse event(s)(through Observation period (up to 44 days))
- Overall success rate(through Observation period (up to 44 days))
- Change in laboratory parameters (10)(through Observation period (up to 44 days))
- Change in laboratory parameters (11)(through Observation period (up to 44 days))
- Change in laboratory parameters (16)(through Observation period (up to 44 days))
- Change in laboratory parameters (13)(through Observation period (up to 44 days))
- Change in laboratory parameters (14)(through Observation period (up to 44 days))
- Change in vital signs (1)(through Observation period (up to 44 days))
- Change in laboratory parameters (15)(through Observation period (up to 44 days))
- Change in vital signs (2)(through Observation period (up to 44 days))
- Overall survival rate(through Observation period (up to 44 days))