Trial Outcomes & Findings for Anidulafungin PK in Infants and Toddlers (NCT NCT00734500)

Results Overview

Area under the curve at steady state

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

5 days

Results posted on

2012-11-21

Participant milestones
Measure	Anidulafungin Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Anidulafungin PK in Infants and Toddlers

Baseline characteristics by cohort
Measure	Anidulafungin n=15 Participants Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Age Continuous	0.22 years STANDARD_DEVIATION 0.32 • n=5 Participants
Age, Customized <=24 months	15 participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

Timeframe: 5 days

Area under the curve at steady state

Outcome measures
Measure	Anidulafungin n=14 Participants Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.	84 µg*h/mL Interval 30.0 to 278.0

Timeframe: During and up to 10 days after last dose of study drug.

Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.

Outcome measures
Measure	Anidulafungin n=15 Participants Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.	8 participants

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Anidulafungin n=15 participants at risk Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Cardiac disorders Death	6.7% 1/15 • Number of events 1

Other adverse events
Measure	Anidulafungin n=15 participants at risk Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Gastrointestinal disorders Direct hyperbilirubinemia	13.3% 2/15 • Number of events 2

Duke University

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