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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01032187
Other study ID # LVTO-I
Secondary ID
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
Health authority
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

Study Design


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
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