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

Sponsors

Lead Sponsor: University of Brasilia

Collaborator: Ministry of Health, Brazil

Source 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.

Overall Status Completed
Start Date 2007-10-01
Completion Date 2010-07-01
Primary Completion Date 2010-01-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Cure rate 3 months
Secondary Outcome
Measure Time Frame
Improvement rate 30 days
Adverse events rate 30 days
Enrollment 101
Condition
Intervention

Intervention Type: Drug

Intervention Name: Meglumine antimoniate

Description: 20mg/kg/day IV for 20 days

Arm Group Label: Meglumine antimoniate

Other Name: Glucantime

Intervention Type: Drug

Intervention Name: Amphotericin B-deoxycholate

Description: Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days

Arm Group Label: Anfo B

Other Name: Fungizone

Eligibility

Criteria:

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: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
Hospital de Doenças Tropicais | Araguaína, Tocantins, Brazil
Hospital Dona Regina | Palmas, Tocantins, Brazil
Location Countries

Brazil

Verification Date

2017-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Brasilia

Investigator Full Name: Gustavo Adolfo Sierra Romero

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Meglumine antimoniate

Type: Active Comparator

Description: 20mg/kg/day IV for 20 days

Label: Anfo B

Type: Experimental

Description: Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days

Acronym LVTO
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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