Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 1
- 主要终点
- Complete Clinical Response
研究概览
简要总结
Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.
So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL.
The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients.
This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.
详细描述
Evaluation of Efficacy and Safety of Miltefosine for Cutaneous Leishmaniasis in Colombia Leishmaniasis is taking dramatic dimensions in Colombia, due to its rapid expansion, reemergence (which has made Colombia became in the second South American country in levels of annual incidence) the appearance of new infection sources, the entrance of the vector to the homes, the urbanization of the disease, the higher population in risk of infection, the absence of adequate medications ( safe, non-expensive, easily available, with oral or topic route of administration) and the higher resistance to the only available medication for its treatment. It is estimated that in 2005 more than 20,000 new cases were diagnosed; 10,265 of them among the Colombian military forces personnel, but it is well known that in most of the rural areas the major proportion of cases are not diagnosed and the people cannot reach to an adequate treatment and they have to use empiric options.
On the other hand, the Program for Research and Control in tropical diseases (PECET) is working among Tropical Diseases Research/World Health Organization(TDR/WHO) in the evaluation of drugs and vaccines against Leishmaniasis; besides, PECET belongs to the TDR/WHO Clinical Monitors groups, TDR/WHO Data Management and participates in the Initiative for Public Health Products Development Doctorate among five Asiatic universities. The Ministry of Social Protection is aware of the need of new therapeutic alternatives for Leishmaniasis and has requested to PECET to conduct a controlled clinical trial to determinate the efficacy and safety of Miltefosine compared with Glucantime for the treatment of Cutaneous Leishmaniasis (CL) in Colombia, even though previous, no conclusive trials, conducted in Guatemala and Colombia, have demonstrated efficacy this could be an alternative of treatment for this country.
Thermomed is a battery-operated medical device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue. Radio frequency energy is directed through the handset to the applicator that is placed in direct contact with the lesion. (the applicator contains a thermocouple to continuously monitor and control temperature to within 50º Celsius. The thermomed has been used for research on treatment for cutaneous leishmaniasis, and recent clinical studies have shown not only clinical improvement, but also that therapy elicits an immune response to the disease. Through this trial we will try to perform a conclusive clinical evaluation about this drug.
In summary, with this project to conduct a clinical trial to determine the efficacy and safety of Miltefosine or thermotherapy compared with Glucantime for treatment of CL in Colombian patients.
Population CL in is a remerging disease in Colombia affecting civilian and military population as well, sharing the same epidemiologic characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Parasitologically proven cases of CL based on positive smear and/or culture.
- •Patients belonging to the National Colombian Army.
- •Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
- •Age 18-40 years.
- •Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits.
- •Abstain to receive any other treatment for CL during the trial and follow-up periods.
- •Non purulent lesions.
- •Mentally sane volunteers.
- •No Leishmaniasis treatment in the six months prior to the recruitment.
- •Number of lesions no more than 5
- •Exclusion criteria:
- •None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal.
- •Serious systemic illnesses (as judged by the physician)
- •Patients with mucosal compromise.
- •Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test)
排除标准
- 未提供
研究组 & 干预措施
Miltefosine
Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
干预措施: Miltefosine (Drug)
Glucantime®
Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
干预措施: Glucantime® (Drug)
Thermotherapy
One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
干预措施: Thermotherapy (Device)
结局指标
主要结局
Complete Clinical Response
时间窗: Until 6 months posttreatment
Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment. Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment.
Failure
时间窗: Until 3 months posttreatment
At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment
次要结局
- Recurrence(Until 6 months post-treatment)