Trial | NCT01032187  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    101
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.
Study Started
Oct 31
2007
Primary Completion
Jan 31
2010
Study Completion
Jul 31
2010
Last Update
Sep 05
2017

Drug Amphotericin B-deoxycholate

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

  • Other names: Fungizone

Drug Meglumine antimoniate

20mg/kg/day IV for 20 days

  • Other names: Glucantime

Meglumine antimoniate Active Comparator

20mg/kg/day IV for 20 days

Anfo B Experimental

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

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
No Results Posted