Comparison Amphotericin B Liposome Neutropenic Pediatric Patients

• Register: EUCTR
• Last refreshed on: 7 April 2015
• Main ID: EUCTR2014-005021-13-Outside-EU/EEA
• Date of registration: 03/04/2015
• Prospective Registration: Yes
• Primary sponsor: Merck & Co., Inc.
• Public title: Comparison Amphotericin B Liposome Neutropenic Pediatric Patients
• Scientific title: A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia - Comparison Amphotericin B Liposome Neutropenic Pediatric Patients
• Target sample size: 100
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005021-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany, Spain, United States

Contacts

• Name: Global Clinical Trials Operations
• Affiliation: Merck & Co., Inc.

• Name: Global Clinical Trials Operations
• Affiliation: Merck & Co., Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female patients are at least 2 years of age and less than 18 years of age at the time of initial screening.
• Patient has received chemotherapy for leukemia, lymphoma, or other cancers or has undergone hematopoietic stem-cell transplantation.
• Patient has had an absolute neutrophil count <500/µL for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding randomization, and has fever >38.0°C within the last 24 hours prior to randomization. Appropriate antibiotics are those that provide broad spectrum Gram-positive and Gramnegative coverage.

Are the trial subjects under 18? yes
Number of subjects for this age range: 82
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Patient has an inadequately managed bacterial infection at the time of enrollment.
• Patient has abnormal laboratory values: 1) Platelet count <5000/µL. 2) INR >1.6 (if patients are receiving anticoagulants, INR>4.0). 3) Bilirubin >3 times upper limit of normal for age. 4) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age.
• Patient has a known documented invasive fungal infection at the time of enrollment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Empirical Therapy in Pediatric Patients

Intervention(s)

Trade Name: Cancidas ™
Product Name: Cancidas™
Product Code: MK-0991
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Caspofungin acetate
CAS Number: 179463-17-3
Current Sponsor code: MK-0991
Other descriptive name: L-743872
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: AmBisome™
Product Name: AmBisome
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Amphotericin B Liposome
CAS Number: 1397-89-3
Other descriptive name: AMPHOTERICINE B, LIPOSOME
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: AmBisome Injection (liposomal amphotericin)
Product Name: AmBisome Injection (liposomal amphotericin)
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Amphotericin B Liposome
CAS Number: 1397-89-3
Other descriptive name: AMPHOTERICINE B, LIPOSOME
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): The proportion of patients treated with one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period.

Timepoint(s) of evaluation of this end point: 1-55 days

Main Objective: To estimate in pediatric patients, aged 2 to 17 years, with persistent fever and neutropenia, the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy.

Secondary Objective: To estimate in pediatric patients (2 to 17 years), who are treated with caspofungin or liposomal amphotericin B for persistent fever and neutropenia: a. The proportion of patients reporting one or more clinical and/or laboratory drug-related serious adverse experience(s) during the study drug therapy period plus 14 days posttherapy. b. The proportion of patients reporting one or more clinical and/or laboratory drug-related adverse experience(s) leading to discontinuation of study therapy. c. The proportion of patients with a favorable overall efficacy outcome.

Secondary Outcome(s)

Secondary end point(s): The proportion of patients treated with one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period.

Timepoint(s) of evaluation of this end point: 1-55 days

Secondary ID(s)

MK-0991-044

Source(s) of Monetary Support

Merck & Co., Inc.