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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Amphotericin B
Amphotericin B, deoxycholate drug combination
Deoxycholic Acid
Liposomal amphotericin B
Meglumine
Meglumine antimoniate
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Cholagogues and Choleretics
Contrast Media
Diagnostic Uses of Chemicals
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014