Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-30 @ 7:01 AM
Study NCT ID:
NCT01946568
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
Sponsor:
Durata Therapeutics Inc., an affiliate of Allergan plc
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: