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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

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

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

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

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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