PER-073-20已完成未知
EFFICACY AND SAFETY OF THERMOTHERAPY IN COMBINATION WITH MILTEFOSINE COMPARED WITH MEGLUMINE ANTIMONIATE AND WITH MILTEFOSINE MONOTHERAPY FOR THE TREATMENT OF CUTANEOUS LEISHMANIASIS IN THE NEW WORLD: A PHASE III, OPEN-LABEL, MULTICENTER AND RANDOMIZED CLINICAL TRIA
DRUGS FOR NEGLECTED DISEASE INITIATIVE,0 个研究点目标入组 0 人开始时间: 2020年12月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •Man or woman aged <:: 12 and S60 years (upper age limit according to local regulations), and weighing 30 kg or more.
- •Patient with a confirmed diagnosis of C in at least one lesion, by at least one of the following methods: 1) microscopic identification of amastigotes in stained injured tissue, 2) demonstration of Leishmania by PCR or 3) culture
- •positive for promastigotes.
- •Patient with an injury that meets the following criteria:
- •- Size> 0.5 cm and <4 cm (maximum diameter).
- •- Not located on the ear, face, near the mucous membranes or in a place where, in the opinion of the IP, it is difficult to apply TT.
- •-Patient with <4 LC lesions.
- •-Injury lasting less than 4 months according to the patient´s history.
- •Patient able to give informed consent / assent in writing.
- •In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
排除标准
- •with a positive urine or blood pregnancy test at the time of screening or who is breastfeeding, or a woman of childbearing potential who does not agree to take appropriate contraceptives during the treatment period and until 0180. In Brazil: women of childbearing age fertile who do not agree to use two effective contraceptive methods: a barrier method and a highly effective method (defined in section 8.2.4) 30 days before the start of treatment and until the visit 0180
- •History of clinically significant medical problems or treatment that may interact, either negatively or positively, with the treatment of cutaneous leishmaniasis, including any disease
- •immunocompromising.
- •Have received treatment for the leishmaniasis entry lesion with any medication, including antimonials, which, in the opinion of the PI, could modify the course of the Leishmania infection, in the 8 weeks (56 days) before D1.
- •Have a diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on a physical examination.
- •ECG at screening: QTc above 400 ms for men and 450 ms for women.
- •Have the following laboratory values at the time of screening:
- •-Serial amylase and lipase: 2 times above the upper normal level *
- •-Serum creatinin: above the upper normal level *
- •-ALT or AST: 3 times above the upper normal level
- •Normal levels are obtained with the local laboratory.
- •Patient who is not willing to attend study consultations or who cannot comply with follow-up consultations until 6 months.
- •Known history of alcohol addiction / abuse.
- •Hypersensitivity to miltefosine or antimonial drugs or to any excipient of the investigational drugs.
- •Patient with Sjogren-Larson Syndrome.
研究者
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