Visceral Leishmaniasis
Conditions
Keywords
Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil
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.
Interventions
20mg/kg/day IV for 20 days
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
Sponsors
Ministry of Health, Brazil
University of Brasilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate | 30 days |
| Adverse events rate | 30 days |
Countries
Brazil
Outcome results
None listed