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

Sponsor

Cumberland Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT02013141

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections	Drug: Telavancin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telavancin Telavancin 10 mg/kg IV administered over one hour one time.	Drug: Telavancin Other Names: VIBATIV TD-6424

Arm

Intervention/Treatment

Experimental: Telavancin

Telavancin 10 mg/kg IV administered over one hour one time.

Drug: Telavancin

Other Names:

VIBATIV

TD-6424

Outcome Measures

Primary Outcome Measures

Pharmacokinetics- AUC (area under curve) [24 hours]

Secondary Outcome Measures

Pharmacokinetics- Cmax [24 hours]
Pharmacokinetics- Tmax [24 hours]
Pharmacokinetics- t1/2 [24 hours]
Pharmacokinetics- CLp (plasma clearance) [24 hours]
AEs (adverse events) [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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