An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years

Theravance Biopharma Antibiotics, Inc.0 个研究点目标入组 32 人开始时间: 2015年7月3日最近更新: 2015年8月4日

适应症

试验速览

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•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

•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

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