Disseminated Leishmaniasis Clinical Trial
Official title:
Efficacy Study of Liposomal Amphotericin in Disseminated Leishmaniasis
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 80 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | HUPES | Salvador | Bahia |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitário Professor Edgard Santos |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Toxicity | Evaluation of side effects and laboratory parameters during the 7 to 15 days of treatment. | During the 7 to 15 days of treatment | Yes |