Telavancin Pediatric PK Study (Ages >3 Months to 17 Years)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 1/17/2019 |
| Start Date: | December 2014 |
| End Date: | December 2020 |
| Contact: | Cumberland Pharmaceuticals Inc. |
| Email: | bkaelin@cumberlandpharma.com |
| Phone: | 1-877-484-2700 |
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
and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV)
over 60 minutes
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
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