EUCTR2016-000656-99-Outside-EU/EEA进行中（未招募）1 期
An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years of Age withSerious Bacterial InfectionsFirst EMA Decision Number of Paediatric Investigational Plan: P/0229/2015 obtained for meropenem (in combination with vaborbactam) - TANGOKIDS
Rempex Pharmaceuticals-Melinta Therapeutics0 个研究点开始时间: 2023年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A signed and dated written informed consent (ICF) from the parent or legal representative and a subject assent (according to local IRB,requirements);
- •2. Male or female from birth to < 18 years of age;
- •3. Are hospitalized, in stable condition, and receiving systemic antibiotics for a known or suspected bacterial infection; or subjects receiving peri-operative prophylactic use of antibiotics;
- •4. The subject will be observed in the hospital for at least 6 hours after the study drug is administered;
- •5. If female and has reached menarche, or has reached Tanner Stage 3 breast development (even if not having reached menarche), the subject is practicing appropriate birth control or is sexually abstinent;
- •6. Sufficient intravascular access (peripheral or central) to receive study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 67
- •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. Signs of severe sepsis;
- •2. 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;
- •3. 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;
- •4. Female adolescent subjects who are pregnant or breastfeeding or have a positive serum ß-human chorionic gonadotropin (hCG) pregnancy test at screening and at pre-dose Day 1;
- •5. Males who are unwilling to practice abstinence or use an acceptablemmethod of birth control during the entire study period (i.e. condom with spermicide);
- •6. Renal function at screening as estimated by creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz bedside formula;
- •7. Treatment within 30 days prior to enrollment with valproic acid;
- •8. Treatment within 30 days prior to enrollment with probenecid;
- •9. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
- •10. Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
- •11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3X ULN or total bilirubin = 1.5X ULN;
- •12. Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
- •13. Previous exposure to vaborbactam or Vabomere;
- •14. Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug
- •administration;
- •15. Known significant hypersensitivity to any beta-lactam antibiotic;
- •16. Unable or unwilling in the judgment of the Investigator, to comply with the protocol;
- •17. Subject is a child of an employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator;
- •18. Body mass index (BMI) outside the range (below the 5th percentile or above the 95th percentile) for height, age and weight except for children < 2 years of age.
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