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

U

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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