Trial Outcomes & Findings for An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants (NCT NCT00942149)

Results Overview

Area under the curve

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

24 hours

Results posted on

2013-07-15

A total of 20 participants were enrolled in the Duke NICU over a period of 18 months.

Participant milestones
Measure	Daptomycin Cohort There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Daptomycin Cohort n=20 Participants There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	0.1 years STANDARD_DEVIATION 0.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

Timeframe: 24 hours

Population: all 20 subjects were analyzed

Area under the curve

Outcome measures
Measure	Area Under the Curve - 24 Hours n=20 Participants pharmacokinetics of daptomycin
PK of Daptomycin	262.4 mg*h/L Full Range .005 • Interval 166.7 to 340.2

Timeframe: 7 days following last dose of study drug

Outcome data not reported

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events
Measure	Daptomycin Cohort n=20 participants at risk
Gastrointestinal disorders Abnormal KUB	5.0% 1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumatocele	10.0% 2/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders possible morgagni cdh	5.0% 1/20 • Number of events 1

Other adverse events
Measure	Daptomycin Cohort n=20 participants at risk
Cardiac disorders patent foramen ovale	10.0% 2/20 • Number of events 2
Blood and lymphatic system disorders unconjugated hyperbilirubinemia	10.0% 2/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders pulmonary edema	10.0% 2/20 • Number of events 2

Duke University Medical Center

Phone: 9196688951