Clinical Trial: Liposomal Amphotericin in Disseminated Leishmaniasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy Study of Liposomal Amphotericin in Disseminated Leishmaniasis

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.


Detailed Summary:
Sponsor: Hospital Universitário Professor Edgard Santos

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Hospital Universitário Professor Edgard Santos

Dates:
Date Received: December 26, 2013
Date Started: April 2011
Date Completion:
Last Updated: December 30, 2013
Last Verified: December 2013