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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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caspofungin acetate

Duration of Treatment 28 Days

Intervention Type DRUG

Other Intervention Names

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MK0991

Eligibility Criteria

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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

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No