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This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meglumine antimoniate | Experimental | Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meglumine antimoniate | Drug | 5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation) | Three months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate - day 7 | Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the first week of treatment | 7th day |
| Adverse events rate - day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia S Ampuero-Vela, MD, MSc | Faculty of Medicine, University of Brasilia | Principal Investigator |
| Gustavo Adolfo S Romero, MD, PhD | Faculty of Medicine, University of Brasilia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Center Unit of Corte de Pedra | Corte de Pedra, Presidente Tancredo Neves | Bahia State | 45416 - 000 | Brazil |
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| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077485 | Meglumine Antimoniate |
| ID | Term |
|---|---|
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the second week of treatment
| 14th day |
| Total Adverse events rate | Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment | 20th day |
| D012876 |
| Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Organic Chemicals |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |