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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals; Theravance Biopharma Antibiotics, Inc.
• Treatments: Telavancin

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