Open-Label, Pharmacokinetics Study of Caspofungin in Neonates and Infants

• Register: EUCTR
• Last refreshed on: 2 March 2015
• Main ID: EUCTR2014-005032-34-Outside-EU/EEA
• Date of registration: 27/02/2015
• Prospective Registration: Yes
• Primary sponsor: Merck & Co., Inc.
• Public title: Open-Label, Pharmacokinetics Study of Caspofungin in Neonates and Infants
• Scientific title: A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age - Open-Label, Pharmacokinetics Study of Caspofungin in Neonates and Infants
• Target sample size: 32
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005032-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Colombia, India, Mexico, Panama, 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:
• Patient is <3 months (90 days) of age on day of informed consent.
• Patient has a documented (culture-confirmed) or suspected invasive Candida infection, as defined below.
• Patient must be receiving an intravenous amphotericin B formulation (amphotericin B deoxycholate or lipid preparation of amphotericin B) for the treatment of a highly-suspected or documented invasive Candida infection at the time of study entry and will remain on an intravenous amphotericin B formulation for the duration of caspofungin study therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
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 is =3 months (=90 days) of age at the time of informed consent.
• Patient has exclusionary laboratory values as listed below: Hematocrit <35% for patients with a body weight of <1500 grams, AST (SGOT) >2 times the upper limit of normal, for age, ALT (SGPT) >2 times the upper limit of normal, for age.
• Patient is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days.
• Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause.



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

Health Condition(s) or Problem(s) studied

Empirical therapy for fungal infections

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

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-

Primary Outcome(s)

Primary end point(s): To evaluate and compare Day 1 C(24-hr) caspofungin plasma concentrations obtained from neonates and infants <3 months of age administered caspofungin at a 25-mg/m2 intravenous (IV) dose

Secondary Objective: 1) To evaluate and compare Day 1 C1 hr caspofungin plasma concentrations obtained from neonates and infants <3 months of age administered caspofungin at a 25-mg/m2 IV dose to historical data from adult patients administered caspofungin at a 50-mg daily IV dose; 2) To evaluate and compare Day 4 C1 hr and C24 hr caspofungin plasma concentrations obtained from neonates and infants <3 months of age administered caspofungin at a 25-mg/m2 daily IV dose to historical data from adult patients administered a 50-mg daily IV dose; 3) To evaluate the safety and tolerability of caspofungin administered at 25 mg/m2/day in neonates and infants <3 months of age.

Main Objective: To evaluate and compare Day 1 C24 hr caspofungin plasma concentrations obtained from neonates and infants <3 months of age administered caspofungin at a 25-mg/m2 intravenous (IV) dose to historical data from adult patients administered caspofungin at a 50-mg daily IV dose.

Timepoint(s) of evaluation of this end point: Day 1

Secondary Outcome(s)

Secondary end point(s): To evaluate and compare Day 1 C(1-hr) caspofungin plasma concentrations obtained from neonates and infants <3 months of age administered caspofungin at a 25-mg/m2 IV dose

Timepoint(s) of evaluation of this end point: Day 1

Secondary ID(s)

MK-0991-058

Source(s) of Monetary Support

Merck & Co., Inc.