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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-005032-34-Outside-EU/EEA
Enrollment
32
Registered
2015-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empirical therapy for fungal infections

Interventions

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

Sponsors

Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patient is =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 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.

Design outcomes

Primary

MeasureTime frame
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.;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. ;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;Timepoint(s) of evaluation of this end point: Day 1—

Secondary

MeasureTime frame
Timepoint(s) of evaluation of this end point: Day 1;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—

Countries

Colombia, India, Mexico, Panama, United States

Contacts

Public ContactGlobal Clinical Trials Operations

Merck & Co., Inc.

dalya_guris@merck.com12673056559

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026