Orange, California 92868

  • Positive Bacterial Infections

Purpose:

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


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


NCT ID:

NCT02013141


Primary Contact:

Study Director
Medical Monitor
Cumberland Pharmaceuticalsc

Cumberland Pharmaceuticals Inc.
Phone: 1-615-255-0068
Email: bkaelin@cumberlandpharma.com


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States

Antonio C. Arrieta, M.D.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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