The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

Study Overview
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Brief Summary
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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.

Official Title
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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil

Conditions
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Leishmaniasis

Intervention / Treatment
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* Drug: Meglumine antimoniate
* Drug: Miltefosine
* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - Mucosal Antimoniate and Pentoxifylline<br>20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days. | Drug: Meglumine antimoniate<br>* 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.<br>Drug: Pentoxifylline<br>* Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.<br>|
| Experimental: Group 2 - Mucosal Miltefosine and Pentoxifylline<br>Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days. | Drug: Miltefosine<br>* Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.<br>* Other names: Miltefosnine;Drug: Pentoxifylline<br>* Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.<br>|
| Experimental: Group 3 - Cutaneous Antimoniate and Pentoxifylline<br>20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days. | Drug: Meglumine antimoniate<br>* 20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.<br>Drug: Pentoxifylline<br>* Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.<br>|
| Experimental: Group 4 - Cutaneous Miltefosine and Pentoxifylline<br>Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days. | Drug: Miltefosine<br>* Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.<br>* Other names: Miltefosnine;Drug: Pentoxifylline<br>* Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure | Complete healing of previous lesions until the 90th day after the begin of the treatment | 90 days | 
| Failure | Lesions fail to heal until the 90th day after the begin of the treatment | 90 days | 
| Relapse | Lesions that reappear on the scar of a previously healed lesion | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline