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 |
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| 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. |
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| 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 |
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| Secondary Outcome |
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| Enrollment | 101 |
| Condition | |
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| 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 |
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| Location |
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| Location Countries |
Brazil |
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| 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) |