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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032187
First Posted: December 15, 2009
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Gustavo Adolfo Sierra Romero, University of Brasilia
  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
Intervention Model: Parallel Assignment
Masking: None (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 Gustavo Adolfo Sierra Romero, University of Brasilia:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Improvement rate [ Time Frame: 30 days ]
  • Adverse events rate [ Time Frame: 30 days ]

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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Gustavo Adolfo Sierra Romero, Associate Professor, University of Brasilia
ClinicalTrials.gov Identifier: NCT01032187     History of Changes
Other Study ID Numbers: LVTO-I
First Submitted: December 14, 2009
First Posted: December 15, 2009
Last Update Posted: September 4, 2017
Last Verified: August 2017

Keywords provided by Gustavo Adolfo Sierra Romero, 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
Anti-Bacterial Agents
Antifungal Agents
Cholagogues and Choleretics
Gastrointestinal Agents