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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT01032187
First received: December 14, 2009
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Meglumine antimoniate
Drug: Amphotericin B-deoxycholate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Adverse events rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: October 2007
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Meglumine antimoniate
20mg/kg/day IV for 20 days
Drug: Meglumine antimoniate
20mg/kg/day IV for 20 days
Other Name: 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 Name: Fungizone

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032187

Locations
Brazil
Hospital de Doenças Tropicais
Araguaína, Tocantins, Brazil
Hospital Dona Regina
Palmas, Tocantins, Brazil
Sponsors and Collaborators
University of Brasilia
Ministry of Health, Brazil
Investigators
Principal Investigator: Myrlena RM Borges, MsC Federal University of Tocantins
Study Chair: Gustavo AS Romero, PhD University of Brasilia
  More Information

No publications provided

Responsible Party: Myrlena Regina Machado Mescouto Borges, Federal University of Tocantins
ClinicalTrials.gov Identifier: NCT01032187     History of Changes
Other Study ID Numbers: LVTO-I
Study First Received: December 14, 2009
Last Updated: March 7, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Brasilia:
Visceral leishmaniasis
Amphotericin B deoxycholate
Meglumine antimoniate
Children
Brazil

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amphotericin B, deoxycholate drug combination
Meglumine antimoniate
Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014