A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Infection

AstraZeneca AB0 个研究点目标入组 32 人开始时间: 2013年6月5日最近更新: 2013年6月10日

适应症

试验速览

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•1.) Male or female children ages =3 months to <18 years 2.) Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed infection, and expected to require hospitalization until after the end of treatment (EOT) evaluations are completed 3.) If female and has reached menarche, or has reached Tanner Stage 3 breast development (even if not having reached menarche), the patient is practicing appropriate birth control or is sexually abstinant 4.) Likely to survive the current illness or hospitalization 5.) Sufficient intravascular access (peripheral or central) to receive study drug.
•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

•1.) History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other ß-lactam antibiotics 2.) If female, currently pregnant or breast feeding or has a positive serum ß hCG pregnancy test 3.) Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before enrolment 4.) BMI outside the range (below the 5th percentile or above the 85th percentile) for height, age and weight except for children < 2 years of age 5.) Babies born prior to 37 weeks gestation (cohort 4 only).

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