NCT03982030撤回4 期
An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of participants with resolution of infection
研究概览
简要总结
The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.
详细描述
A phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dalbavancin
Experimental
Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.
干预措施: Dalbavancin (Drug)
结局指标
主要结局
Number of participants with resolution of infection
时间窗: Week 6
Number of participants with no recurrent signs or symptom of infection
次要结局
- Number of participants loss to follow-up - week 6(Week 6)
- Number of participants with hospital readmission - Month 6(Month 6)
- Number of participants with development of breakthrough infection - week 6(Week 6)
- Number of participants with need for further surgical intervention - Month 6(Month 6)
- Number of adverse events leading to discontinuation of study drug - Month 6(Month 6)
- Number of participants with hospital readmission - week 6(Week 6)
- Number of participants with need for further surgical intervention - week 6(Week 6)
- Participant Study Questionnaire week 4(week 4)
- Participant Study Questionnaire week 24(Month 6)
- Number of participants with new enrollment in addiction treatment(Month 6)
- Number of participants with development of breakthrough infection - Month 6(Month 6)
- Number of adverse events leading to discontinuation of study drug -week 6(Week 6)
- Number of participants with reported overdose(Month 6)
- Number of participants re-admitted for addiction-related issue(Month 6)
- Number of participants loss to follow-up - Month 6(Month 6)
- Costs of antibiotic therapy(Month 6)
- Time investment per patient required to follow this model(6 months)
研究者
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