Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

NCT ID: NCT01032187

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-07-31

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.

Conditions

Visceral Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meglumine antimoniate

20mg/kg/day IV for 20 days

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type: DRUG

20mg/kg/day IV for 20 days

Anfo B

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

Group Type: EXPERIMENTAL

Amphotericin B-deoxycholate

Intervention Type: DRUG

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

Interventions

Meglumine antimoniate

20mg/kg/day IV for 20 days

Intervention Type: DRUG

Amphotericin B-deoxycholate

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

Intervention Type: DRUG

Other Intervention Names

Glucantime; 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Adolfo Sierra Romero

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myrlena RM Borges, MsC

Role: PRINCIPAL_INVESTIGATOR

Federal University of Tocantins

Gustavo AS Romero, PhD

Role: STUDY_CHAIR

University of Brasilia

Locations

Hospital de Doenças Tropicais

Araguaína, Tocantins, Brazil

Hospital Dona Regina

Palmas, Tocantins, Brazil

Countries

Brazil

References

Borges MM, Pranchevicius MC, Noronha EF, Romero GA, Carranza-Tamayo CO. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Rev Soc Bras Med Trop. 2017 Jan-Feb;50(1):67-74. doi: 10.1590/0037-8682-0455-2016.

Reference Type: RESULT

PMID: 28327804 (View on PubMed)

Other Identifiers

LVTO-I

Identifier Type: -

Identifier Source: org_study_id