Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Phase 4

Completed

• Conditions: Visceral Leishmaniasis
• Interventions: Drug: Amphotericin B-deoxycholate; Drug: Meglumine antimoniate

• Registration Number: NCT01032187
• Lead Sponsor: University of Brasilia

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.

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2010-01
• Study Completion: 2010-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anfo B	Amphotericin B-deoxycholate	Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days
Meglumine antimoniate	Meglumine antimoniate	20mg/kg/day IV for 20 days

Primary Outcome Measures

Name	Time	Method
Cure rate	3 months

Secondary Outcome Measures

Name	Time	Method
Adverse events rate	30 days
Improvement rate	30 days

Trial Locations

Locations (2)

Hospital de Doenças Tropicais; 🇧🇷 Araguaína, Tocantins, Brazil

Hospital Dona Regina; 🇧🇷 Palmas, Tocantins, Brazil