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Liposomal Amphotericin in Disseminated Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02025491
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : January 1, 2014
Information provided by (Responsible Party):
Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a) clinical diagnosis of Disseminated Leishmaniasis according to case definition; b) illness duration of less than three months, c) parasite identification by culture or polymerase chain reaction methods, d) no previous treatment for leishmaniasis.

Exclusion Criteria:

  • a) immunodeficiency or antibodies to HIV, b) pregnancy or patients not willing or unable to use contraceptives during and 3 months after the end of therapy c) ALT, AST ≥3x normal reference values, creatinine and BUN ≥1.5x normal reference values, d) any evidence of serious underlying disease (cardiac, renal, hepatic, or pulmonary) including serious infection other than DL.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02025491

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Salvador, Bahia, Brazil, 40000
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
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Principal Investigator: Paulo RL Machado, MD PhD UFBA
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paulo Roberto Lima Machado, MD PhD, Hospital Universitário Professor Edgard Santos Identifier: NCT02025491    
Other Study ID Numbers: DLLipoBA001
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: January 1, 2014
Last Verified: December 2013
Keywords provided by Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos:
Disseminated leishmaniasis
Liposomal Amphotericin B
Leishmania braziliensis
Additional relevant MeSH terms:
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Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents