The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A… (NCT02530697) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
Brazil160 participantsStarted 2015-08
Plain-language summary
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
* For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
* Ages between 18 and 80 years old;
* Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
* Agree to participate in the study and sign the informed consent term.
Exclusion Criteria:
* Use of any leishmanicidal drugs six months prior;
* Clinical or laboratorial evidences of electrocardiographic disorders;
* Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
* Hypersensitivity to meglucamine antimoniate;
* Pregnancy or lactation;
* Fertile females that do not agree to use contraceptive methods;
* Patients that do not agree to the informed consent term.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.