Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children (LVTO)

August 31, 2017 updated by: Gustavo Adolfo Sierra Romero, University of Brasilia

Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children

The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B deoxycholate. All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

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
    • Tocantins
      • Araguaína, Tocantins, Brazil
        • Hospital de Doenças Tropicais
      • Palmas, Tocantins, Brazil
        • Hospital Dona Regina

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

6 months to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly
  • Diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rK39 rapid test)or positive kDNA PCR test

Exclusion Criteria:

  • Any of the following laboratory findings

    • Total serum bilirubin higher than 2,5 mg/dL
    • Serum SGOT higher than 5 times the upper normal level
    • Serum SGPT higher than 5 times the upper normal level
    • Prothrombin time concentration lower than 70%
    • Abnormal serum creatinine

  • Any of the following signs or symptoms

    • Generalized edema
    • Severe malnutrition
    • Systemic inflammatory response syndrome

  • Any of the following conditions

    • HIV infection/disease
    • Diabetes
    • Corticoid or immunosuppressive drugs use
    • Symptomatic heart diseases
    • Chronic hepatic or renal diseases
    • Lupus erythematosus

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Meglumine antimoniate
20mg/kg/day IV for 20 days
Drug: Meglumine antimoniate
20mg/kg/day IV for 20 days
Other Names:
  • Glucantime
EXPERIMENTAL: Anfo B
Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days
Drug: Amphotericin B-deoxycholate
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
Other Names:
  • Fungizone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cure rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement rate
Time Frame: 30 days
30 days
Adverse events rate
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

University of Brasilia

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Myrlena RM Borges, MsC, Federal University of Tocantins
  • Study Chair: Gustavo AS Romero, PhD, University of Brasilia

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

October 1, 2007

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

December 14, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (ESTIMATE)

December 15, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVTO-I

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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