WithdrawnPhase 3

Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients

Stopped: The trial was finalized due to major administrative and contractual delays.

Brazil0Started 2025-01-30

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

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

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 …

What they're measuring

Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment.

Timeframe: during the 24-month follow-up

Trial details

NCT IDNCT06339710

SponsorEvandro Chagas Institute of Clinical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-30