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
- Conditions
- -B551 Cutaneous leishmaniasisCutaneous leishmaniasisB551
- Registration Number
- PER-073-20
- Lead Sponsor
- DRUGS FOR NEGLECTED DISEASE INITIATIVE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A physician from the participating center will perform a blind assessment of the injury during the consultation at D90<br>Measure:Proportion of patients with initial clinical cure<br>Timepoints:D90<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:A physician from the participating center will perform a blind assessment of the patient during the consultation at D90<br>Measure:A. Clinical improvement<br>B. Initial healing<br>C. Treatment discontinuation<br>D. Injury ratio<br>Timepoints:A. Clinical improvement: D90 and D105<br>B. Initial healing: D90 or D105 D180<br>C. Treatment discontinuation: during all study visits<br>D. Injury ratio: D90, D105 and D80<br>