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Chagas drug shows promise for kids in landmark trial

NCT ID NCT04024163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • CEADES - Plataforma de Chagas Sucre

    Sucre, Bolivia

  • Centro de Atención e Investigación Médica (CAIMED)

    Yopal, Colombia

  • Centro de Enfermedad de Chagas y Patologías Regionales

    Santiago del Estero, Argentina

  • Fundación Salud para el Trópico

    Santa Marta, Colombia

  • Hospital "Luis Carlos Lagomaggiore"

    Mendoza, Argentina

  • Hospital Pediatrico "Dr. Humberto Notti"

    Mendoza, Argentina

  • Hospital Público Descentralizado Dr. Guillermo Rawson

    San Juan, Argentina

  • Hospital de Ninos "Dr. Ricardo Gutierrez"

    Buenos Aires, Argentina

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