An Open Label Study to Describe the Pharmacokinetics of D... | NCT00942149

Studies
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

NCT00942149

Sponsor

Duke University

Status

Completed

Last Update Posted

Jul 15, 2013Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Sepsis

Interventions

Daptomycin

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

Participant Flow Module

Pre-assignment Details

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

ID	Type	Description	Link
dapto1	Other Identifier	DUMC

Status Module

Record Verification Date

Jun 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

Jan 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 2, 2009

First Submission Date that Met QC Criteria

Jul 17, 2009

First Posted Date

Jul 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Oct 18, 2012

Results First Submitted that Met QC Criteria

Nov 15, 2012

Results First Posted Date

Dec 12, 2012Estimated

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

Jul 1, 2013

Last Update Posted Date

Jul 15, 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 is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours and < 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Daptomycin cohort	Experimental		Drug: Daptomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daptomycin	Drug	single dose of 6 mg/kg of daptomycin	Daptomycin cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK of Daptomycin	Area under the curve	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events Will be Monitored.		7 days following last dose of study drug

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 48 hours and <120 days of age at the time of daptomycin administration
Sufficient venous access to permit administration of study medication
Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

History of anaphylaxis attributed to daptomycin
Previous participation in the study
Exposure to daptomycin in the month prior to the study
Serum creatinine >1.0 mg/dL
Concomitant administration of tobramycin

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
P Brian Smith, MD MHS	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

ID	Title	Description
FG000	Daptomycin Cohort	There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Daptomycin Cohort	There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

PK of Daptomycin

Area under the curve

all 20 subjects were analyzed

Posted

Median

Full Range

mg*h/L

24 hours

ID	Title	Description
OG000	Area Under the Curve - 24 Hours	pharmacokinetics of daptomycin

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Daptomycin Cohort

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abnormal KUB	Gastrointestinal disorders		Non-systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
patent foramen ovale	Cardiac disorders		Non-systematic Assessment

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Brian Smith	Duke University Medical Center	9196688951		brian.smith@duke.edu

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017576	Daptomycin

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D055666	Lipopeptides

Browse Leaves

Not provided

Browse Branches

Not provided