Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Overview

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.

Full Title of Study: “Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

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.

Interventions

  • Drug: Meglumine antimoniate
    • 20mg/kg/day IV for 20 days
  • Drug: Amphotericin B-deoxycholate
    • Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days

Arms, Groups and Cohorts

  • Active Comparator: Meglumine antimoniate
    • 20mg/kg/day IV for 20 days
  • Experimental: Anfo B
    • Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • Cure rate
    • Time Frame: 3 months

Secondary Measures

  • Improvement rate
    • Time Frame: 30 days
  • Adverse events rate
    • Time Frame: 30 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Brasilia
  • Collaborator
    • Ministry of Health, Brazil
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gustavo Adolfo Sierra Romero, Associate Professor – University of Brasilia
  • Overall Official(s)
    • Myrlena RM Borges, MsC, Principal Investigator, Federal University of Tocantins
    • Gustavo AS Romero, PhD, Study Chair, University of Brasilia

Citations Reporting on Results

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.

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