Liposomal Amphotericin in Disseminated Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT02025491|
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : January 1, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Disseminated Leishmaniasis||Drug: Liposomal Amphotericin B||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Study of Liposomal Amphotericin in Disseminated Leishmaniasis|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Liposomal Amphotericin
Liposomal Amphotericin by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment.
Drug: Liposomal Amphotericin B
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.
Other Name: Ambisome
- Definitive cure [ Time Frame: 3 months after treatment ]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.
- Toxicity [ Time Frame: During the 7 to 15 days of treatment ]Evaluation of side effects and laboratory parameters during the 7 to 15 days of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025491
|Salvador, Bahia, Brazil, 40000|
|Principal Investigator:||Paulo RL Machado, MD PhD||UFBA|