Double Blind, Phase III Randomized,Safety and Efficacy Non-inferiority Trial to Evaluate Two Short Benznidazole Regimens for the Treatment of Adults in the Chronic Phase of Chagas Disease in Its Indeterminate and Mild Cardiac Forms in Bolivia and Colombia

U1111-1288-5508

Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects. The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events.

2024-05-01

2026-01-30

2026-10-30

Not yet recruiting

Early phase I

672

Inclusion Criteria:o Adults aged ≥ 18 years; * CD diagnosis through the positivity of two serological tests that use different antigens (recombinant and native antigens, according to World Health Organization (WHO) recommendations) (28). * Informed consent form read and signed by the participant. * Weight ≥ 50 kg to ≤ 95 kg. Exclusion Criteria: * o Currently pregnant, breastfeeding or expressing gestational desire for the next 2 months. * Previously received treatment with Benznidazole (BZN) or NIfurtimox (NFX) - (either completely or incompletely); * Any concomitant use or documented history of using allopurinol or antifungals (ketoconazole, itraconazole and posaconazole); * History of hypersensitivity, allergic or serious adverse event (SAE) to any "nitroimidazole", and/or its components; * Acute or chronic health problems that, in the informed opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the drug. Examples are acute infections, Human Immunodeficiency Virus (HIV) infections, liver disease with liver failure and kidney disease requiring support treatment; * Signs and/or symptoms of severe cardiac form of CD ; * History of cardiomyopathy, heart failure or severe ventricular arrhythmia of any etiology; * Alcoholic participants or those with a history of alcohol abuse (considered as intake of \>4 drinks on any single day AND \>14 drinks per week for men and \>3 drinks on any single day AND \>7 drinks per week for women); * Have basic laboratory parameters outside the normal range or parameters that are considered clinically relevant by the physician responsible for the participant; * Participation in another clinical trial over the past 12 months.

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2024-04-01