Visceral Leishmaniasis Clinical Trial
— LVTOOfficial title:
Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children
Verified date | August 2017 |
Source | University of Brasilia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Doenças Tropicais | Araguaína | Tocantins |
Brazil | Hospital Dona Regina | Palmas | Tocantins |
Lead Sponsor | Collaborator |
---|---|
University of Brasilia | Ministry of Health, Brazil |
Brazil,
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
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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