Clinical trial NCT03511820: A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever
Official title: A Post Marketing Surveillance Study of Lipo-AB® (Amphotericin B) in Neutropenic Patients With Persistent Fever
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia, Febrile
Keywords: Amphotericin B
liposome
post marketing surveillance
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neutropenic patients with persistent fever who are recommended to receive systemic antifungal therapy based on physician's decision will be invited to participate in this study.

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.

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 criteria: 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

Primary outcomes:
measure: Incidence rate of nephrotoxicity
timeFrame: through Observation period (up to 44 days)
Secondary outcomes:
measure: Categorization of the change in renal function
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (1)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (2)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (3)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (4)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (5)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (6)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (7)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (8)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (9)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (10)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (11)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (12)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (13)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (14)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (15)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (16)
timeFrame: through Observation period (up to 44 days)
measure: Change in laboratory parameters (17)
timeFrame: through Observation period (up to 44 days)
measure: Change in vital signs (1)
timeFrame: through Observation period (up to 44 days)
measure: Change in vital signs (2)
timeFrame: through Observation period (up to 44 days)
measure: Change in vital signs (3)
timeFrame: through Observation period (up to 44 days)
measure: Adverse event(s)
timeFrame: through Observation period (up to 44 days)
measure: Overall success rate
timeFrame: through Observation period (up to 44 days)
measure: Overall survival rate
timeFrame: through Observation period (up to 44 days)
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei city
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Mucinipal Wanfang Hospital
city: Taoyuan
country: Taiwan
facility: Chang Guang Memorial Hospital at LinKou
Study officials:
References: