Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas … (NCT04024163) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
Argentina178 participantsStarted 2019-09-19
Plain-language summary
This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.
Who can participate
Age range2 Years – 18 Years
SexALL
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Inclusion Criteria:
* Age between 2 years and 18 years (age limits inclusive)
* Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
* Written informed consent by parent/legal representative and informed assent from patients if \>7 years old when applicable (as requirements may vary by country and by site)
* Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment
Exclusion Criteria:
* Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
* Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
* Signs and/or symptoms of acute Chagas Disease
* Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
* History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
* Immunocompromised (clinical history compatible with human immunodeficiency virus (HIV) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive …