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
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
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- CmaxPharmacokinetics- Tmax Pharmacokinetics- t1/2 Pharmacokinetics- CLp AEs
Eligibility
Minimum age: 1 Year.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
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