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

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

MedlinePlus related topics:

Yeast Infections

ChemIDplus related topics:

Caspofungin Caspofungin Acetate

U.S. FDA Resources

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.

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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_025, MK0991-058
First Received:	May 24, 2006
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00330395
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mycoses

Candidiasis

Clotrimazole

Miconazole

Caspofungin

Tioconazole

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

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