Chagas drug shows promise for kids in landmark trial
NCT ID NCT04024163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug benznidazole can cure chronic Chagas disease in children aged 2 to 18. All 178 participants receive the drug, and their results are compared to a historical placebo group. The main goal is to see if the infection clears based on blood tests over 72 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Benznidazole
- What this could lead to
- If successful, this could confirm benznidazole as an effective treatment to clear Chagas infection in children, potentially preventing long-term heart and digestive complications.
- What could go wrong
- This is a single-arm study with historical controls, not a randomized blinded trial, so results may be less reliable. The follow-up is long (72 months), and serological cure may not fully predict clinical outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
178 people
The number who actually took part.
- Started
-
Sep 2019
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 drugs) * Abnormal laboratory test values (as per protocol-specified ranges) at Screening for the following parameters: total white blood cell (WBC) count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine * Abnormal ECG (as per protocol-specified ranges) and/or any Chagas disease associated findings * Any condition that prevents the patient from taking oral medication * Patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (IMP) * Evidence or history of alcohol or drug abuse (within the last 12 months) * Any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment * Employee of the Investigator or trial centre, or family member of the employees or the Investigator * Any condition that, in the opinion of the Investigator, may jeopardise the trial conduct according to the protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Antigua Hospital Viedma
Cochabamba, Bolivia
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CEADES - Plataforma de Chagas Sucre
Sucre, Bolivia
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Centro de Atención e Investigación Médica (CAIMED)
Yopal, Colombia
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Centro de Enfermedad de Chagas y Patologías Regionales
Santiago del Estero, Argentina
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Fundación Salud para el Trópico
Santa Marta, Colombia
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Hospital "Luis Carlos Lagomaggiore"
Mendoza, Argentina
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Hospital Pediatrico "Dr. Humberto Notti"
Mendoza, Argentina
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Hospital Público Descentralizado Dr. Guillermo Rawson
San Juan, Argentina
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Hospital de Ninos "Dr. Ricardo Gutierrez"
Buenos Aires, Argentina
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