Population Pharmacokinetics Study of Benznidazole in Children With Chagas'Disease

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the population pharmacokinetics parameters of benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.

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

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborator: LAT Research
• Treatments: Benzonidazole

Criteria

Inclusion Criteria:

• Age between newborn (1day) - 12 years

• Diagnosis of T. cruzi infection by:

• Direct microscopic examination or

• Conventional serology, at least two positive tests (ELISA, IIF or HAI)

• Written informed consent form by parent/ legal representative

• Children assent if > 7 years

Exclusion Criteria:

• Pre-term (< 37 weeks gestational age) or weight < 2500 g

• Female subject who has reached menarche

• Subjects presenting any other acute or chronic health conditions, that in the opinion of the PI, may interfere with the PK, efficacy and/or safety evaluation of the study drug

• Known history of hypersensitivity or serious adverse reactions to nitro- imidazoles

• History of CD treatment with benznidazole or nifurtimox in the past

• Immunocompromised patients (clinical history compatible with HIV infection, primary immunodeficiency or prolonged treatment with corticosteroids or other immunosuppressive drugs)

• Abnormal laboratory test values at screening for the following parameters: total WBC count, platelet count, ALT, AST, total bilirubin and creatinine.

Exception for this criterion is considered for newborns with congenital Chagas Disease, for whom ALT/AST and bilirubin will not be considered exclusion criteria unless considered clinically significant by the investigator.

• Inability to comply with follow-up and/or not having a permanent address

• Any condition that prevents the subject from taking oral medication