{
  "abstract": "Introduction Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.Methods and analysis NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.Ethics and dissemination In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.Trial registration number NCT04897516.",
  "authors": [
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Tayná Marques"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Colin Forsyth"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Fabiana Barreira"
    },
    {
      "affiliations": [
        "Laboratorio ELEA Phoenix S.A, Buenos Aires, Argentina"
      ],
      "name": "Carola Lombas"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Bethania Blum de Oliveira"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Mónica Laserna"
    },
    {
      "affiliations": [
        "International Health Unit Vall d'Hebron-Drassanes, Infectious Diseases Department, Vall d’Hebron University Hospital, Barcelona, Spain",
        "Centro de Investigación Biomédica en Red Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain",
        "Fundação Oswaldo Cruz, Belo Horizonte, Brazil"
      ],
      "name": "Israel Molina"
    },
    {
      "affiliations": [
        "Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’, Corrientes, Argentina"
      ],
      "name": "Maria del Carmen Bangher"
    },
    {
      "affiliations": [
        "Centro de Chagas y Patología Regional, Hospital Independencia, Santiago del Estero, Argentina"
      ],
      "name": "Rosmiro Javier Fernández"
    },
    {
      "affiliations": [
        "Hospital de Infecciosas Dr. Francisco Javier Muñiz, Buenos Aires, Argentina"
      ],
      "name": "Susana Lloveras"
    },
    {
      "affiliations": [
        "Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’, Buenos Aires, Argentina"
      ],
      "name": "Marisa Liliana Fernández"
    },
    {
      "affiliations": [
        "Hospital Donación Francisco Santojanni, Buenos Aires, Argentina"
      ],
      "name": "Pablo Scapellato"
    },
    {
      "affiliations": [
        "Fundación Huésped, Buenos Aires, Argentina"
      ],
      "name": "Patricia Patterson"
    },
    {
      "affiliations": [
        "Centro de Investigación en Enfermedades Transmitidas por Vectores-SEDES Chuquisaca, Sucre, Bolivia"
      ],
      "name": "Wilson Garcia"
    },
    {
      "affiliations": [
        "Plataforma de Atención Integral a los Pacientes con Enfermedad de Chagas, Tarija, Bolivia",
        "Universidad Autónoma Juan Misael Saracho, Tarija, Bolivia"
      ],
      "name": "Lourdes Ortiz"
    },
    {
      "affiliations": [
        "Laboratorio de Biología Molecular de la Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular Dr. Héctor N Torres(INGEBI), Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina"
      ],
      "name": "Alejandro Schijman"
    },
    {
      "affiliations": [
        "Laboratório de Virologia e Parasitologia Molecular, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil"
      ],
      "name": "Otacilio C Moreira"
    },
    {
      "affiliations": [
        "Instituto de Investigaciones Biomédica (IIBISMED), Universidad Mayor de San Simon, Cochabamba, Bolivia"
      ],
      "name": "Lineth García"
    },
    {
      "affiliations": [
        "Berry Consultants, LLC, Austin, Texas, USA"
      ],
      "name": "Kert Viele"
    },
    {
      "affiliations": [
        "Laboratorio de Biología Molecular de la Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular Dr. Héctor N Torres(INGEBI), Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina"
      ],
      "name": "Silvia Longhi"
    },
    {
      "affiliations": [
        "Luxembourg Institute of Health, Strassen, Luxembourg"
      ],
      "name": "Michel Vaillant"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Geneva, Switzerland"
      ],
      "name": "Craig Tipple"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Geneva, Switzerland"
      ],
      "name": "Laurent Fraisse"
    },
    {
      "affiliations": [
        "Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil"
      ],
      "name": "Andrea Silvestre-Sousa"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil"
      ],
      "name": "Sergio Sosa-Estani"
    },
    {
      "affiliations": [
        "Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil",
        "Centro de Investigación Biomédica en Red Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "María-Jesús Pinazo"
    }
  ],
  "title": "New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial",
  "uid": "8603d4b1-a6ce-5cf5-a87d-2767235f9d8c"
}