Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Visceral Leishmaniasis

Intervention / Treatment
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* Drug: Meglumine antimoniate
* Drug: Amphotericin B-deoxycholate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meglumine antimoniate<br>20mg/kg/day IV for 20 days | Drug: Meglumine antimoniate<br>* 20mg/kg/day IV for 20 days<br>* Other names: Glucantime;|
| Experimental: Anfo B<br>Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days | Drug: Amphotericin B-deoxycholate<br>* Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days<br>* Other names: Fungizone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate |  | 30 days | 
| Adverse events rate |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil