An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 48 人开始时间: 2011年12月5日最近更新: 2012年3月19日

适应症

试验速览

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•Must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement
•Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics
•Patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age
•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: 48
•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 as deemed appropriate by the investigator
•Clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator
•Patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure
•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 indwelling 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

发起方

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium