NCT01946568

A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc · Industry
• Sex: All
• Age: 3 Months – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bacterial Infections.

Interventions

Type	Name	Description
DRUG	Dalbavancin	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-09-19
• Last updated: 2015-06-23

Locations

12 sites across 2 countries: United States, Estonia