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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis

Intervention: caspofungin acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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).

Clinical Details

Official 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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic parameters of drug exposure

Secondary outcome: Safety and tolerability


Minimum age: N/A. Maximum age: 3 Months. Gender(s): Both.


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

Locations and Contacts

Additional Information

Related publications:

Sáez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.

Starting date: May 2006
Last updated: December 7, 2014

Page last updated: August 20, 2015

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