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

Primary Purpose

Visceral Leishmaniasis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Meglumine antimoniate
Amphotericin B-deoxycholate
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visceral Leishmaniasis focused on measuring Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Doenças Tropicais
  • Hospital Dona Regina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Meglumine antimoniate

Anfo B

Arm Description

20mg/kg/day IV for 20 days

Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days

Outcomes

Primary Outcome Measures

Cure rate

Secondary Outcome Measures

Improvement rate
Adverse events rate

Full Information

First Posted
December 14, 2009
Last Updated
August 31, 2017
Sponsor
University of Brasilia
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01032187
Brief Title
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
Acronym
LVTO
Official Title
Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Leishmaniasis
Keywords
Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meglumine antimoniate
Arm Type
Active Comparator
Arm Description
20mg/kg/day IV for 20 days
Arm Title
Anfo B
Arm Type
Experimental
Arm Description
Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
20mg/kg/day IV for 20 days
Intervention Type
Drug
Intervention Name(s)
Amphotericin B-deoxycholate
Other Intervention Name(s)
Fungizone
Intervention Description
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
Primary Outcome Measure Information:
Title
Cure rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement rate
Time Frame
30 days
Title
Adverse events rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrlena RM Borges, MsC
Organizational Affiliation
Federal University of Tocantins
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo AS Romero, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Doenças Tropicais
City
Araguaína
State/Province
Tocantins
Country
Brazil
Facility Name
Hospital Dona Regina
City
Palmas
State/Province
Tocantins
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
28327804
Citation
Borges MM, Pranchevicius MC, Noronha EF, Romero GA, Carranza-Tamayo CO. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Rev Soc Bras Med Trop. 2017 Jan-Feb;50(1):67-74. doi: 10.1590/0037-8682-0455-2016.
Results Reference
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Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

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