Liposomal Amphotericin in Disseminated Leishmaniasis

December 30, 2013 updated by: Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40000
        • HUPES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Ambisome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 7 to 15 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitário Professor Edgard Santos

Investigators

  • Principal Investigator: Paulo RL Machado, MD PhD, UFBA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLLipoBA001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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