Bacterial Infections. Clinical Trial
Official title:
A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety and Tolerability Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections
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.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label