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NCT02013141 Clinical Trial

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

Gram-Positive Bacterial Infections Clinical Trial

Official title:
An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 3 Months to 17 Years

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02013141
Other study ID # 0101
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date March 2021

Study information
Verified date February 2022
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Telavancin

Locations
Country Name City State
United States Children's Hospital of Orange County Orange California

Sponsors (1)
Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics- AUC (area under curve) 24 hours
Secondary Pharmacokinetics- Cmax 24 hours
Secondary Pharmacokinetics- Tmax 24 hours
Secondary Pharmacokinetics- t1/2 24 hours
Secondary Pharmacokinetics- CLp (plasma clearance) 24 hours
Secondary AEs (adverse events) 24 hours
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