Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330395

Enrollment

Registered

2006-05-26

Start date

2006-05-31

Completion date

2006-10-31

Last updated

2017-02-23

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

Conditions

Candidiasis

Brief summary

The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).

Interventions

DRUGcaspofungin acetate

Duration of Treatment 28 Days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy volunteers

Inclusion criteria

* Neonates and infants \<3 months of age * Patient has a body weight greater than or equal to 500 grams * Patient has documented or highly suspected Candida infection

Exclusion criteria

* Patient is greater than 3 months of age * Patient has a body weight of less than 500 grams * Patient does not meet certain laboratory testing criteria * Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days * Patient has documented HIV infection of any stage * Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters of drug exposure	—

Secondary

Measure	Time frame
Safety and tolerability	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026