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Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease

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Trial Profile

Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2024

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At a glance

  • Drugs Nifurtimox (Primary)
  • Indications Chagas disease
  • Focus Registrational; Therapeutic Use
  • Acronyms CHICO; CHICO SECURE
  • Sponsors Bayer

    • Most Recent Events

    • 28 Mar 2023 Primary endpoint (Incidence Rate of Seronegative Conversion for Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen (Part 2) has been met according to Results published in the Antimicrobial Agents and Chemotherapy.
    • 28 Mar 2023 Results assessing Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease at 4-Year Follow-Up published in the Antimicrobial Agents and Chemotherapy
    • 07 Aug 2020 According to a Bayer media release, the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi), based on the data from this trial.

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