Liposomal Amphotericin in Disseminated Leishmaniasis

Phase 3

Completed

• Conditions: Disseminated Leishmaniasis
• Interventions: Drug: Liposomal Amphotericin B

• Registration Number: NCT02025491
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-02
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-30
• Last Update Submitted: 2013-12-30
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liposomal Amphotericin	Liposomal Amphotericin B	Liposomal Amphotericin by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment.

Primary Outcome Measures

Name	Time	Method
Definitive cure	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

Name	Time	Method
Toxicity	During the 7 to 15 days of treatment	Evaluation of side effects and laboratory parameters during the 7 to 15 days of treatment.

Trial Locations

Locations (1)

HUPES; 🇧🇷 Salvador, Bahia, Brazil