An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 YearChronological Age

Janssen-Cilag International NV,0 个研究点目标入组 10 人开始时间: 2012年3月21日最近更新: 2013年7月22日

适应症

试验速览

暂无简介。

•-Patient is expected to require hospitalization for the entire open-label phase of the study.
•- Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a spinal tap) or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.
•- Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV
•antibiotics.
•- Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•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

•-Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.
•- Any condition at screening that, in the
•opinion of the investigator, may interfere with the assessments of this study.
•- Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before
•- History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.
•- Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.
•- Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.
•- Patients concomitantly treated with probenecid or valproic acid (VPA).

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