A Phase 4 interventional study of Meglumine antimoniate and Amphotericin B-deoxycholate in Visceral Leishmaniasis, sponsored by University of Brasilia. Completed at 2 sites in Brazil. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by University of Brasilia · Phase 4, Interventional, and Treatment
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.
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's enrollment of 101 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →University of Brasilia is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Any of the following laboratory findings
Any of the following signs or symptoms
Any of the following conditions
20mg/kg/day IV for 20 days
Drug: Meglumine antimoniate
Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days
Drug: Amphotericin B-deoxycholate
20mg/kg/day IV for 20 days
Also known as: Glucantime
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
Also known as: Fungizone
Cure rate
Time frame: 3 months
Improvement rate
Time frame: 30 days
Adverse events rate
Time frame: 30 days
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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University of Brasilia