NCT01032187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

December 14, 2009

Last Update Submit

August 31, 2017

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasisAmphotericin B deoxycholateMeglumine antimoniateChildrenBrazil

Outcome Measures

Primary Outcomes (1)

  • Cure rate

    3 months

Secondary Outcomes (2)

  • Improvement rate

    30 days

  • Adverse events rate

    30 days

Study Arms (2)

Meglumine antimoniate

ACTIVE COMPARATOR

20mg/kg/day IV for 20 days

Drug: Meglumine antimoniate

Anfo B

EXPERIMENTAL

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

Drug: Amphotericin B-deoxycholate

Interventions

Meglumine antimoniateDRUG

20mg/kg/day IV for 20 days

Also known as: Glucantime
Meglumine antimoniate
Amphotericin B-deoxycholateDRUG

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

Also known as: Fungizone
Anfo B

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Doenças Tropicais

Araguaína, Tocantins, Brazil

Location

Hospital Dona Regina

Palmas, Tocantins, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 28327804RESULT

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Meglumine Antimoniateamphotericin B, deoxycholate drug combinationAmphotericin B

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsHexosaminesAmino SugarsCarbohydratesMacrolidesPolyketidesLactones

Study Officials

  • Myrlena RM Borges, MsC

    Federal University of Tocantins

    PRINCIPAL INVESTIGATOR

  • Gustavo AS Romero, PhD

    University of Brasilia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 15, 2009

Study Start

October 1, 2007

Primary Completion

January 1, 2010

Study Completion

July 1, 2010

Last Updated

September 5, 2017

Record last verified: 2017-08

Locations

BR(2)