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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
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
December 11, 2013
Last Updated
February 1, 2022
Sponsor
Cumberland Pharmaceuticals
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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

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Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)

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