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An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gram-Positive Bacterial Infections

Intervention: Telavancin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
Maria Pecoraro, MD, MPH, Study Director, Affiliation: Theravance Biopharma Antibiotics, Inc.

Overall contact:
Wayne Yates, Phone: 650-808-4118, Email: wyates@theravance.com


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

Clinical Details

Official title: An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Pharmacokinetics- AUC

Secondary outcome:

Pharmacokinetics- Cmax

Pharmacokinetics- Tmax

Pharmacokinetics- t1/2

Pharmacokinetics- CLp



Minimum age: 1 Year. Maximum age: 17 Years. Gender(s): Both.


Inclusion Criteria: Subject is 1 to 17 years (inclusive) and has a height/length/weight (for subjects between 12 and 23 months) or body mass index (BMI, for subjects 2 to 17 years) within the 5th to 95th percentile (inclusive) for age and sex. Subject requires intravenous antibiotics for:

- Gram-positive bacterial infection OR

- prophylaxis of Gram-positive infection OR

- empiric therapy for suspected Gram-positive infection

Exclusion Criteria: Subject has an estimated creatinine clearance <50 mL/min/1. 73 m2 (Schwartz formula). Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e. g., vancomycin), telavancin, or the formulation excipients. Subject requires concomitant vancomycin treatment.

Locations and Contacts

Wayne Yates, Phone: 650-808-4118, Email: wyates@theravance.com

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting
David Speicher
Additional Information

Starting date: December 2014
Last updated: July 27, 2015

Page last updated: August 23, 2015

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