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

February 1, 2022 updated by: Cumberland Pharmaceuticals

An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 3 Months to 17 Years

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telavancin
Telavancin 10 mg/kg IV administered over one hour one time.
Drug: Telavancin
Other Names:
  • TD-6424
  • VIBATIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics- AUC (area under curve)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics- Cmax
Time Frame: 24 hours
24 hours
Pharmacokinetics- Tmax
Time Frame: 24 hours
24 hours
Pharmacokinetics- t1/2
Time Frame: 24 hours
24 hours
Pharmacokinetics- CLp (plasma clearance)
Time Frame: 24 hours
24 hours
AEs (adverse events)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Investigators

  • Study Director: Medical Monitor, Cumberland Pharmaceuticalsc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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