Chronic Chagas DiseasePhase 3BenlatinoNCT06339710
Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients
A Phase 3 study testing benznidazole 300 mg daily 8 weeks in people with Chronic Chagas Disease, run by Evandro Chagas Institute of Clinical Research at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Chagas Disease
- What is being tested?
- benznidazole 300 mg daily 8 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Jan 2025to 30 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Israel Molina
Minas Gerais, Belo Horizonte
Monique Gurgel de Oliveira
Rio de Janeiro, Rio de Janeiro, 24350211
About this study
Official title: 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
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.
Read the detailed description
Chagas disease is a major cause of heart disease, morbidity, and premature loss of life in the Americas. Eliminating the Trypanosoma cruzi parasite using antitrypanosomal drugs has shown to produce cure in children, halt future congenital transmission, and reduce morbidity from the disease. However, the current treatment regimens are lengthy (60 days) and entail frequent side effects, causing about 20% of patients to drop out of treatment, and discouraging others from starting. Recent research found that a reduced treatment of benznidazole still has adequate efficacy with few side effects.
In this international, multicenter, double-blind, phase III, placebo-controlled study, 672 participants will be randomly assigned to receive the standard-dose of benznidazole (300 mg daily for 8 weeks) or the short experimental regimens (benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks). Efficacy will be assessed considering a non-inferiority design and through the detection of parasite deoxyribonucleic acid (DNA) through molecular biology (Polymerase Chain Reaction - PCR). Meanwhile, safety will be evaluated through a superiority design, with the aim to find the new regimen as effective as the standard one, but superior in terms of safety. An intention-to-treat analysis will be performed, and statistical significance will be set at 0.025 for the non-inferiority outcome (positive PCR) and 0.05 for the superiority outcome.
The study population will be adult participants, 18 years or older, with chronic Chagas disease in its indeterminate or mild cardiac forms, with a positive diagnosis from two serological assays. The trial will be conducted in four sites: two in Bolivia, and two in Colombia. The primary endpoint will be parasitological response determined as sustained negative qualitative PCR at 24 months after treatment. The proportion of participants with positive qualitative PCR will be measured at 1, 4, 6, 8, 12, 18, and 24 months from end of treatment. The frequency of adverse events leading to treatment discontinuation will be compared. An economic evaluation will be conducted assessing the direct and indirect costs, including procedures associated with the management of adverse events.
- Conditions
- Chronic Chagas Disease
- Being tested
- benznidazole 300 mg daily 8 weeks
- Keywords
- Chagas disease, Short treatment, Benznidazole
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benznidazole 300 mg daily 8 weeksDrug
Also called benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks, benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks
672 participants will be randomly assigned to receive the standard-dose of benznidazole (300 mg daily for 8 weeks) or the short experimental regimens (benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Short treatment 1 | Experimental | benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or Receives: Drug: benznidazole 300 mg daily 8 weeks |
| Short Treatment 2 | Experimental | benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks Receives: Drug: benznidazole 300 mg daily 8 weeks |
| Standard treatment | Active comparator | benznidazole 300 mg daily for 8 weeks Receives: Drug: benznidazole 300 mg daily 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment.
The treatment efficacy of each treatment arm is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 24 months after starting treatment
Measured: during the 24-month follow-up
Secondary outcomes (2)
Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period
The safety profile will me measured with the proportion of patients with treatment discontinuation atributed to the drug toxicity in each treatment arm
Measured: during treatment period (up to 8 weeks)
Proportion of participants with positive PCR at different time points
Parasitic kinetics will be evaluated by detecting parasitic DNA measured by qualitative PCR in peripheral blood in 1, 4, 6, 8, 12, 18 and 24 months after the end of treatment in each of the different therapeutic regimens.
Measured: At the different time points: 1, 4, 6, 8, 12, 18 and 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start30 Jan 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Why it stopped: The trial was finalized due to major administrative and contractual delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evandro Chagas Institute of Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Andrea Silvestre de Sousa
- Responsible party
- Principal investigator, Israel Molina, Evandro Chagas Institute of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339710
- Sponsor's protocol ID
- U1111-1288-5508
- Acronym
- Benlatino
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06339710
- Acronym / sponsor ID
- Benlatino / U1111-1288-5508
- Conditions
- Chronic Chagas Disease
- Keywords
- Chagas disease, Short treatment, Benznidazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was finalized due to major administrative and contractual delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Evandro Chagas Institute of Clinical ResearchUniversity, hospital or other
- Collaborators
- Andrea Silvestre de Sousa
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chagas disease is a major cause of heart disease, morbidity, and premature loss of life in the Americas. Eliminating the Trypanosoma cruzi parasite using antitrypanosomal drugs has shown to produce cure in children, halt future congenital transmission, and reduce morbidity from the disease. However, the current treatment regimens are lengthy (60 days) and entail frequent side effects, causing about 20% of patients to drop out of treatment, and discouraging others from starting. Recent research found that a reduced treatment of benznidazole still has adequate efficacy with few side effects.
In this international, multicenter, double-blind, phase III, placebo-controlled study, 672 participants will be randomly assigned to receive the standard-dose of benznidazole (300 mg daily for 8 weeks) or the short experimental regimens (benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks). Efficacy will be assessed considering a non-inferiority design and through the detection of parasite deoxyribonucleic acid (DNA) through molecular biology (Polymerase Chain Reaction - PCR). Meanwhile, safety will be evaluated through a superiority design, with the aim to find the new regimen as effective as the standard one, but superior in terms of safety. An intention-to-treat analysis will be performed, and statistical significance will be set at 0.025 for the non-inferiority outcome (positive PCR) and 0.05 for the superiority outcome.
The study population will be adult participants, 18 years or older, with chronic Chagas disease in its indeterminate or mild cardiac forms, with a positive diagnosis from two serological assays. The trial will be conducted in four sites: two in Bolivia, and two in Colombia. The primary endpoint will be parasitological response determined as sustained negative qualitative PCR at 24 months after treatment. The proportion of participants with positive qualitative PCR will be measured at 1, 4, 6, 8, 12, 18, and 24 months from end of treatment. The frequency of adverse events leading to treatment discontinuation will be compared. An economic evaluation will be conducted assessing the direct and indirect costs, including procedures associated with the management of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short treatment 1 | Experimental | Drug: benznidazole 300 mg daily 8 weeksbenznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or |
| Short Treatment 2 | Experimental | Drug: benznidazole 300 mg daily 8 weeksbenznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks |
| Standard treatment | Active comparator | Drug: benznidazole 300 mg daily 8 weeksbenznidazole 300 mg daily for 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- o Currently pregnant, breastfeeding or expressing gestational desire for the next 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benznidazole 300 mg daily 8 weeksAlso: benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks, benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks672 participants will be randomly assigned to receive the standard-dose of benznidazole (300 mg daily for 8 weeks) or the short experimental regimens (benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks) | Drug | Short Treatment 2, Short treatment 1, Standard treatment |
Primary outcome
Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment.
Time frame: during the 24-month follow-up
The treatment efficacy of each treatment arm is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 24 months after starting treatment
2 secondary outcomes
Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period
Time frame: during treatment period (up to 8 weeks)
Proportion of participants with positive PCR at different time points
Time frame: At the different time points: 1, 4, 6, 8, 12, 18 and 24 months after the end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing benznidazole 300 mg daily 8 weeks in people with Chronic Chagas Disease, run by Evandro Chagas Institute of Clinical Research at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment. (time frame: during the 24-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.