EUCTR2013-005415-26-Outside-EU/EEA进行中（未招募）不适用
An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age with Suspected or Confirmed Bacterial Infections - ORKIDS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females <18 years of age
- •2. Neonates must be at least 34 weeks post-conception age
- •3. Written informed consent before initiation of any study-related procedures. Parent or legal guardian has given informed consent, as appropriate; and pediatric subject has given verbal assent where appropriate.
- •4. Suspected or confirmed Gram positive bacterial infection receiving antibiotic therapy
- •5. Intravenous access to administer study drug
- •6. In the investigator’s opinion, the subject will require hospitalization for at least 24 hours after the study drug is administered.
- •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
排除标准
- •1. Septic shock or acute haemodynamic instability.
- •2. History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, or teicoplanin) or any of their excipients.
- •3. Currently using vancomycin or other glycopeptides
- •4. Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant) during the entire study period.
- •5. Female subjects of childbearing potential who are lactating or who have a positive pregnancy test result at screening coordinator, other staff or relative thereof directly involved in the conduct of the study.
- •6. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide).
- •7. Any surgical or medical condition which, in the opinion of the investigator, would put the subject at increased risk or is likely to interfere with study procedures or PK of the study drug.
- •8. Subjects whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study (eg, unlikely to survive 60 days from initiation of study drug or unlikely to return for the Day 14 follow-up visit).
- •9. Treatment with investigational medicinal product or investigational device within 30 days (or 5 times the half-life of the investigational medicine, whichever is longer) before enrollment and for the duration of the study.
- •10. Subjects who are taking heparin or warfarin and/or require anticoagulant monitoring (aPTT, PT, INR).
- •11. Subjects with AST or ALT > 3xULN or total bilirubin = 2 ULN.
- •12. Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3.
- •13. Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, metabolic or cardiovascular disease.
- •14. Currently receiving cytotoxic chemotherapy or immunosuppressive therapy with tacrolimus or cyclosporine
- •15. Previous participation in this study
- •16. Subject is the child of the investigator or his/her deputy, research assistant, pharmacist, study
研究者
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