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Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis | Experimental |
| |
| Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis | Experimental |
| |
| Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis | Active Comparator |
| |
| Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miltefosine 50mg | Drug | Oral Miltefosine 50mg bid |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Presence laboratorial or clinica changes during treatment that lead to treatment interruption | 30 days after drug interruption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raimunda Sampaio, PhD | Contact | +556120285415 | rnrsampaio@hotmail.com | |
| Sofia Martins, PhD | Contact | +556120285415 | sofiasalesm@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Brasilia | Recruiting | BrasÃlia | Federal District | 70840-901 | Brazil |
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| Pentoxifylline 400mg | Drug | Oral Pentoxifylline 400mg tid |
|
| Liposomal Amphotericin B | Drug | Intravenous 25 to 40mg/kg |
|
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D007897 | Leishmaniasis, Mucocutaneous |
| ID | Term |
|---|---|
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016773 | Leishmaniasis, Cutaneous |
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| ID | Term |
|---|---|
| C039128 | miltefosine |
| D010431 | Pentoxifylline |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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