A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
This is a open label, multi center study to investigate the pharmacokinetics, safety and tolerability of a single dose of intravenous dalbavancin in hospitalized pediatric patients with known or suspected bacterial infection. Patients will be enrolled and results will be evaluated in 3 age cohorts as follows: Cohort 1: Patients 6 years to 11 years of age, inclusive; Cohort 2: Patients 2 years to \<6 years of age; Cohort 3: Patients 3 months to \<2 years of age. All patients in each cohort will be administered a single dose of dalbavancin in addition to background anti infective treatment to be chosen by the investigator according to standard of care. Pharmacokinetic samples will be obtained at various timepoints. Dalbavancin can be administered at any time (before, during or after) the standard of care therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
36
Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients \<5 years of age.
University Arkansas Medical Center
Little Rock, Arkansas, United States
University of California, San Diego
San Diego, California, United States
Connecicut Children's Hospital
Hartford, Connecticut, United States
To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
Duke Medical Center
Durham, North Carolina, United States
Pediatric Pharmacology
Toledo, Ohio, United States
Texas Children's Hospital - Clinical Care Center
Houston, Texas, United States
...and 2 more locations
To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.
Time frame: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).
Time frame: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.
Time frame: one year