An Open-Label Study of the Safety and Pharmacokinetics of... | NCT00818584

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

NCT00818584

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Mar 6, 2013Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Candida

Interventions

Micafungin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jan 6, 2009

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2013

Last Update Posted Date

Mar 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. micafungin lower dose	Experimental		Drug: Micafungin
2. micafungin higher dose	Experimental		Drug: Micafungin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micafungin	Drug	IV Administration	1. micafungin lower dose 2. micafungin higher dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of micafungin plasma pharmacokinetic parameters		Day 4

Secondary Outcomes

Measure	Description	Time Frame
Monitor adverse events		11 or 12 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Hours

Maximum Age

120 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Use Central Contact	Astellas Pharma US, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35233	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19890251	Background	Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sanchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins