Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Study Overview
=================
Brief Summary
-----------------
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

Official Title
-----------------
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Conditions
-----------------
Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous

Intervention / Treatment
-----------------
* Drug: Miltefosine 50mg
* Drug: Pentoxifylline 400mg
* Drug: Liposomal Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase Agree and sing informed consent form Exclusion Criteria: Previous treatment with leishmanicidal drugs in the last 6 months Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms) Serum creatinine or urea 1.5 times the upper limit of normal Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline Pregnant and breastfeeding women Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis<br> | Drug: Miltefosine 50mg<br>* Oral Miltefosine 50mg bid<br>Drug: Pentoxifylline 400mg<br>* Oral Pentoxifylline 400mg tid<br>|
| Experimental: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis<br> | Drug: Miltefosine 50mg<br>* Oral Miltefosine 50mg bid<br>Drug: Pentoxifylline 400mg<br>* Oral Pentoxifylline 400mg tid<br>|
| Active Comparator: Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis<br> | Drug: Liposomal Amphotericin B<br>* Intravenous 25 to 40mg/kg<br>|
| Active Comparator: Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis<br> | Drug: Liposomal Amphotericin B<br>* Intravenous 25 to 40mg/kg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure | Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration) | 90 days after the begin of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Presence laboratorial or clinica changes during treatment that lead to treatment interruption | 30 days after drug interruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment