An Open-Label, Parallel-Group Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem inPediatric Patients 3 Months to 17 Years of Age, Inclusive

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.0 个研究点目标入组 50 人开始时间: 2012年3月5日最近更新: 2012年3月20日

研究概览

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•- Boy or girl between 3 months and 17 years of age, inclusive.
•- Suspected or diagnosed bacterial infection for which the patient is receiving standard antibiotic therapy
•- Otherwise healthy patients as confirmed by the investigator, after review of the subject's medical history, physical examination (including vital signs) and clinical laboratory tests
•- Subject's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age
•- Menarchal girls must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout study; have a negative urine or serum beta-human chorionic gonadotropin pregnancy test at screening.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•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

•- History of hypersensitivity (allergic reaction) reactions to carbapenems and penicillins or other beta lactam antibiotics
•- Known or suspected to have cystic fibrosis
•- History of hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) or central line is used
•- Known or suspected impairment of renal function
•- Patients concomitantly treated with or having received imipenem/cilastatin within 2 days before study drug administration
•- Patients concomitantly treated with probenecid or valproic acid
•-If a menarchal girl, is pregnant, is planning to become pregnant during the study, or is currently breastfeeding a child

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