Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Improvement of index lesion at EoT
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia.
The study will compare three treatment groups:
- Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks.
- Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks.
- Control Group: SSG only, with no topical treatment.
The primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT).
A total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, 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
Treatment - SoC + fusidic acid 2% cream
4 weeks SSG (SoC) with 2 weeks twice daily topical application of fusidic acid 2% cream
干预措施: Fusidic Acid (Drug)
Vehicle - SoC + vehicle cream
4 weeks SSG (SoC) with 2 weeks twice daily topical application of vehicle cream
干预措施: Vehicle cream (Other)
结局指标
主要结局
Improvement of index lesion at EoT
时间窗: 28 days
To assess if 4 weeks SoC with 2 weeks application of 2% fusidic acid twice per day (Arm 1, Treatment) is superior to 4 weeks SoC only (Arm 3, Control) for complicated CL patients, in terms of reaching at least substantial improvement\* of the index lesion\*\* at the end of treatment (EoT). \*Substantial improvement is defined as \>50% flattening and \>50% re-epithelization compared to the baseline assessment. Improvement will be measured for each lesion. At least the index lesion needs to be improved or cured for a patient to be considered substantially improved. \*\*Index lesion is defined as the largest lesion eligible for treatment.
次要结局
- Cycles needed for final cure(180 days)
- Proportion of cured patients at day 180(180 days)
- Arm 1 superiority to arm 3 - index lesion(42 days)
- Arm 1 superiority to arm 3 - lesions eligible for treatment(42 days)
- Proportion of participants that reach substiantial improvement - arm 1 vs arm 2(42 days)
- Proportion of participants that reach substiantial improvement - arm 2 vs arm 3(42 days)
- Quality of life - patient reported outcome(180 days)
- Safety and acceptability(180 days)
- Stability microbial diversity(180 days)
- Correlation microbial diversity and substantial improvement(180 days)
- Correlation microbial diversity and cure without relapse(180 days)
- Increase microbial diversity(180 days)