CompletedPhase 4

Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

Brazil101 participantsStarted 2007-10

Plain-language 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.

Who can participate

Age range6 Months – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cure rate

Timeframe: 3 months

Trial details

NCT IDNCT01032187

SponsorUniversity of Brasilia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Visceral Leishmaniasis trials