Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Visceral Leishmaniasis Clinical Trial

— LVTO  

Official title:

Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032187
• Other study ID #: LVTO-I
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2009
• Last updated: August 31, 2017
• Start date: October 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2017
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Drug:
• Meglumine antimoniate
20mg/kg/day IV for 20 days
• Amphotericin B-deoxycholate
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days

Locations

Country	Name	City	State
Brazil	Hospital de Doenças Tropicais	Araguaína	Tocantins
Brazil	Hospital Dona Regina	Palmas	Tocantins

Sponsors (2)

Lead Sponsor	Collaborator
University of Brasilia	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate		3 months
Secondary	Improvement rate		30 days
Secondary	Adverse events rate		30 days