Phase II Open Randomized Clinical & Health Economic Trial Comparing Intralesional Antimony Therapy Versus Wound Care Management in Old World Cutaneous Leishmaniasis Patients in Northern Afghanistan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Wound closure time
研究概览
简要总结
The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:
- The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
- The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.
Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who
- •Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.
排除标准
- •Patients with more than one lesion are excluded.
- •Patients with a lesion age of > 3 months are also excluded. The experience of the Kabul trial shows that patients presenting themselves for the first time with a lesion, which is older than three months, have either been pre-treated somewhere else and/or show a poor compliance during the trial.
- •Patients below 12 years of age have to be excluded from the trial, because they cannot fill in the EQ-5D and Skindex questionnaire part of the health economic evaluation.
- •Intralesional antimony injections are too painful for lesions located on the nose, lips or eyes. Therefore, patients presenting these lesions are excluded from the trial.
- •For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial.
- •Patients with major uncontrolled diseases as tuberculosis, diabetes or HIV are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.
研究组 & 干预措施
IL SSG
Intralesional sodium stibogluconate
干预措施: Sodium Stibogluconate (Drug)
ETC+MWT
Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
干预措施: Electro-thermo-coagulation (Procedure)
ETC+MWT
Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
干预措施: DAC N-055 (Drug)
MWT
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
干预措施: DAC N-055 (Drug)
结局指标
主要结局
Wound closure time
时间窗: 75 days
次要结局
- Leishmania load parasites per gram of tissue before and after treatment(75 days)
- Cost-effectiveness & -utility(75 days)