Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients (NCT06339710) | Clinical Trial Compass
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 range
18 Years – 60 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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