Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)
Primary Purpose
Gram-Positive Bacterial Infections
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Sponsored by
About this trial
This is an interventional basic science trial for Gram-Positive Bacterial Infections focused on measuring Gram positive bacteria, Telavancin, VIBATIV, Pediatric, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Subject is aged >3 months to 17 years (inclusive) and has a weight within the 3rd to 97th percentile (inclusive) for age and sex
- Subject requires or recently completed systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection
Exclusion Criteria:
- Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz equation)
- Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients
- Subject has clinically relevant cardiac abnormality, in the opinion of the investigator
- Subject was treated with an investigational drug within 30 days or five half-lives, whichever is longer, before study entry
Sites / Locations
- Children's Hospital of Orange County
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telavancin
Arm Description
Telavancin 10 mg/kg IV administered over one hour one time.
Outcomes
Primary Outcome Measures
Pharmacokinetics- AUC (area under curve)
Secondary Outcome Measures
Pharmacokinetics- Cmax
Pharmacokinetics- Tmax
Pharmacokinetics- t1/2
Pharmacokinetics- CLp (plasma clearance)
AEs (adverse events)
Full Information
NCT ID
NCT02013141
First Posted
December 11, 2013
Last Updated
February 1, 2022
Sponsor
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02013141
Brief Title
Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)
Official Title
An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 3 Months to 17 Years
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
FDA waived the pediatric study requirement for this application
Study Start Date
December 2014 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections
Keywords
Gram positive bacteria, Telavancin, VIBATIV, Pediatric, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telavancin
Arm Type
Experimental
Arm Description
Telavancin 10 mg/kg IV administered over one hour one time.
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
VIBATIV, TD-6424
Primary Outcome Measure Information:
Title
Pharmacokinetics- AUC (area under curve)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics- Cmax
Time Frame
24 hours
Title
Pharmacokinetics- Tmax
Time Frame
24 hours
Title
Pharmacokinetics- t1/2
Time Frame
24 hours
Title
Pharmacokinetics- CLp (plasma clearance)
Time Frame
24 hours
Title
AEs (adverse events)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is aged >3 months to 17 years (inclusive) and has a weight within the 3rd to 97th percentile (inclusive) for age and sex
Subject requires or recently completed systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection
Exclusion Criteria:
Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz equation)
Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients
Subject has clinically relevant cardiac abnormality, in the opinion of the investigator
Subject was treated with an investigational drug within 30 days or five half-lives, whichever is longer, before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Cumberland Pharmaceuticalsc
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)
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