PACTR201812819039144招募中3 期
Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX)
Kumasi Centre for Collaborative Research0 个研究点目标入组 142 人开始时间: 2018年12月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
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
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •i.Male or female patients aged between 5 years and 80 years inclusive.
- •ii.Buruli lesion (ulcer, nodule or plaque) iii.The lesion must have been tested positive for M. ulcerans by PCR for IS2404
- •iv.Able to give informed consent/assent for minors.
- •v.Able and willing (or have parents/carers able and willing) to follow the protocol requirements
排除标准
- •i.Female patients who are pregnant or breast-feeding.
- •ii.Any other serious disease likely to compromise the outcome of the trial.
- •iii.Participation in any interventional study during the 2 weeks (or 5 half-lives of the investigational product, if longer) preceding the intervention period of the study.
- •iv.Currently taking antibiotics that could interact with the trial medication.
- •v.Known allergy to any of the oral antibiotics or components of EDX dressing
研究者
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