Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00330395

Purpose

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).

Condition	Intervention	Phase
Candidiasis	Drug: caspofungin acetate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Pharmacokinetic parameters of drug exposure

Secondary Outcome Measures:

Safety and tolerability

Enrollment:	16
Study Start Date:	May 2006
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment 28 Days

Eligibility

Ages Eligible for Study:	up to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330395

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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. Epub 2008 Dec 15.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_025, MK0991-058
Study First Received:	May 24, 2006
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00330395 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Echinocandins
Candidiasis

Therapeutic Uses
Antifungal Agents
Caspofungin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009