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Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases.
DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Amphotericin | Experimental | Liposomal Amphotericin by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Amphotericin B | Drug | Liposomal Amphotericin B will be administered by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment. Complete hemogram, aminotransferases (AST, ALT), blood urea and creatinine will be determined in all patients on days -1, and three times/week up to the end of therapy. Patients will bemonitored for side effects daily. Patients will be followed-up at 1, 2, 3, 4 and 6 months post-therapy. Clinical and laboratory adverse events will be graded according to the Common Toxicity Criteria (CTC) of the National Cancer Institute. |
| Measure | Description | Time Frame |
|---|---|---|
| Definitive cure | Definitive cure at 3 months after the end of treatment is defined as complete epithelialization of all ulcers and complete disappearance of inflammatory infiltrations from all lesions. | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Evaluation of side effects and laboratory parameters during the 7 to 15 days of treatment. | During the 7 to 15 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulo RL Machado, MD PhD | UFBA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUPES | Salvador | Estado de Bahia | 40000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26048961 | Derived | Machado PR, Rosa ME, Guimaraes LH, Prates FV, Queiroz A, Schriefer A, Carvalho EM. Treatment of Disseminated Leishmaniasis With Liposomal Amphotericin B. Clin Infect Dis. 2015 Sep 15;61(6):945-9. doi: 10.1093/cid/civ416. Epub 2015 Jun 5. |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
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