NCT00198601已完成4 期
Determination of Gentamicin Dosing in Neonatal Patients for Use in the Uniject Pre-filled Syringe [A Three-site Study at: 1) Dhaka Shishu Hospital, Dhaka Bangladesh; 2) Christain Medical Center, Vellore, India; and 3) Aga Khan University Medical Center, Karachi, Pakistan]
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
研究概览
简要总结
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
详细描述
This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants with culture proven sepsis
- •infants 2000-2499 at birth
- •infants > 2500 gm at birth
- •infants < 2000 gm at birth
- •in study site areas: Pakistan, Bangladesh and India
排除标准
- •infants w/o culture proven sepsis
结局指标
主要结局
Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
Low peak<4.0: none
High trough > 2.0: 1/6 patients
次要结局
- High peak>12.0: 2/14 patients
- Low peak <4.0: none
- High trough>2.0:2/14 patients
- Patients 2.5-3.0 kg
研究者
研究点 (3)
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