NCT01032187

Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-01-01
• Completion: 2010-07-01
• First posted: 2009-12-15
• Last updated: 2017-09-05

Locations

2 sites across 1 country: Brazil