Pharmacokinetic Study in Children Aged 1 to 17 Years After Administration of a Single Dose of Telavanci

Conditions: Gram-Positive Bacterial Infections
MedDRA version: 18.0Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2015-002218-60-Outside-EU/EEA

Lead Sponsor: Theravance Biopharma Antibiotics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 32

Inclusion Criteria

Subject is 1 to 17 years (inclusive) and has a height/length/weight (for subjects between 12 and 23 months) or body mass index (BMI, for subjects 2 to 17 years) within the 5th to 95th percentile (inclusive) for age and sex.

Subject requires intravenous antibiotics for:
•Gram-positive bacterial infection OR
•prophylaxis of Gram-positive infection OR
•empiric therapy for suspected Gram-positive infection

Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject has an estimated creatinine clearance <50 mL/min/1.73 m2 (Schwartz formula).

Subject requires concomitant vancomycin treatment.

Subject requires concomitant administration of agents containing cyclodextrin

Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the pharmacokinetics of telavancin after a single dose in pediatric subjects (1 to 17 years) who require intravenous antibiotic therapy (other than vancomycin) for the treatment of Gram-positive infection;Secondary Objective: To assess the safety and tolerability of telavancin after a single dose in pediatric subjects (1 to 17 years) who require intravenous therapy (other than vancomycin) for Gram-positive infection;Primary end point(s): PK parameters: <br>- Cmax, Tmax, AUC0-t, AUC0-inf, t1/2, CLp, and Vdss (plasma) <br>- Ae, fe, and CLr (urine).;Timepoint(s) of evaluation of this end point: Blood: Predose and 0.5, 1.0, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours after the beginning of the infusion<br>Urine: Predose and postdose intervals of 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At screening, Day 1, Day 2, D3/Early Termination and Follow Up (Day 8 ± 1 Day);Secondary end point(s): Safety variables including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, concomitant medication usage, and adverse event reporting.