Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children (LVTO)

University of Brasilia

Status and phase: Completed; Phase 4

Conditions: Visceral Leishmaniasis

Treatments: Drug: Amphotericin B-deoxycholate; Drug: Meglumine antimoniate

Study type: Interventional

Funder types: Other

Identifiers

NCT01032187

LVTO-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Meglumine antimoniate

Active Comparator group

Description:

20mg/kg/day IV for 20 days

Treatment:

Drug: Meglumine antimoniate

Anfo B

Experimental group

Description:

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

Treatment:

Drug: Amphotericin B-deoxycholate