An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

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

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-10-31

Brief Summary

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This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

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Detailed Description

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Subjects will be stratified by weight to receive one of two doses of study drug

Conditions

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Candida

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1. micafungin lower dose

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV Administration

2. micafungin higher dose

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV Administration

Interventions

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Micafungin

IV Administration

Intervention Type DRUG

Other Intervention Names

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Mycamine FK463

Eligibility Criteria

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Inclusion Criteria

* Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
* Infant has sufficient venous access to permit study drug dosing
* Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion Criteria

* Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
* Infant has received an echinocandin within one month prior to study entry
* Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
* Infant has a life expectancy of less than 96 hours

Minimum Eligible Age

48 Hours

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No