Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Brasilia
• Collaborator: Ministry of Health, Brazil
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B; Meglumine Antimoniate

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