EUCTR2017-000953-38-BG进行中（未招募）1 期
A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old - A Single-and Multiple-dose Study of Tedizolid Phosphate in Pediatric Subjects Aged < 2 Years Old
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.0 个研究点目标入组 42 人开始时间: 2017年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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. Be a male or female aged birth to <24 months
- •2.Be hospitalized and receiving prophylaxis for or have a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity. The most recent dose of concurrent antibiotic treatment should be administered within 24 hours prior to randomization,except for concurrent long-acting antibiotics that are administered once (eg, dalbavancin, oritavancin).
- •3.Be at least 1 kg in weight.
- •4.Be in stable condition as determined from medical history, physical examination, electrocardiogram (ECG [minimally 5-lead]; ECG not required for neonates), vital signs, and clinical laboratory evaluations.
- •5.Have no cardiac or electrocardiogram (ECG) finding which in the opinion of the investigator would limit the subject's ability to complete and/or participate in this clinical study. For neonates, an ECG is not required, but ECG data will be collected if available.
- •6. Have serum creatinine within 1.5x upper limit of the reference range based on age
- •7. Have parents willing to adhere to the prohibitions and restrictions specified in this protocol.
- •8. Have sufficient vascular access to receive trial drug (for subjects enrolled in Part A) and allow for blood draws required by the protocol.
- •9. Have consent: Parents or subjects’ legally acceptable representative(s) provide documented informed consent indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study.
- •10. Be able to receive medication by mouth, for subjects to be dosed with oral suspension; dose administration via feeding tube is acceptable.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •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. Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the investigator.
- •2. Has any acute or chronic condition that, in the opinion of the investigator, would limit the subject’s ability to complete and/or participate in this clinical study.
- •3. Has used rifampin within 14 days prior to dosing.
- •4. Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for subjects in Part B, i.e., oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing.
- •5. Recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease
- •6. Has a history of drug allergy or hypersensitivity to oxazolidinones
- •7. Has had significant blood loss (=5% of total blood volume) for Groups 2, 3, 5, and 6 and significant blood loss within 4 weeks for Groups 1 and 4 before the Screening Visit. Total blood volume can be estimated as 80 mL per kg of body weight.
- •8. Need for oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. (Administration during the follow-up period is allowed, as is administration during treatment with IV study drug).
- •9. Use of MAOIs or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans) meperidine, or buspirone within 14 days prior to study, or planned use while on study.
- •10. Has received another investigational product within the 30 days prior to enrollment.
- •11. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
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