protocolSection identificationModule nctId: NCT06339710, orgStudyIdInfo id: U1111-1288-5508, briefTitle: Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients, acronym: Benlatino, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Evandro Chagas Institute of Clinical Research, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Chagas Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 672, type: ESTIMATED, armsInterventionsModule interventions name: benznidazole 300 mg daily 8 weeks, outcomesModule primaryOutcomes measure: Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment., secondaryOutcomes measure: Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period, secondaryOutcomes measure: Proportion of participants with positive PCR at different time points, otherOutcomes measure: Incidence and severity of clinically relevant events attributed to Chagas disease, otherOutcomes measure: To measure the quality of life (QoL) of participants, otherOutcomes measure: To measure the quality of life (QoL) of participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Israel Molina, city: Minas Gerais, state: Belo Horizonte, country: Brazil, contacts name: CARLA Renata TREVIA, role: CONTACT, phone: 21996670525, email: renatasantos@cuidachagas.org, contacts name: Monique MG Gurgel, Master, role: CONTACT, phone: +55 21 997248094, email: moniquegurgel@cuiachagas.org, contacts name: Andrea Silvestre De Sousa, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -8.96667, lon: -72.78333, locations facility: Carla Renata Ferreira Dos Santos Trevia, city: Rio De Janeiro, state: RJ, zip: 22631390, country: Brazil, contacts name: Israel IM Molina, PHD, role: CONTACT, phone: +34 679337605, email: israel.molina@fiocruz.gov, contacts name: Monique MG Gurgel, Master, role: CONTACT, phone: +55 21 997248094, email: moniquegurgel@uidachagas.gov, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Carla Renata Ferreira dos Santos Trevia, city: Rio de Janeiro, state: RJ, zip: 22790-790, country: Brazil, contacts name: Israel IM Molina, PHd, role: CONTACT, phone: +34 679 33 76 05, email: israel.molina@fiocruz.gov, contacts name: Monique MG Gurgel, Master, role: CONTACT, phone: +55 21, contacts name: Israel IM Molina, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ana Gabriela AH Herrera, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Ximena MX Escalante Lazcano, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario MO Mario Oliveira, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan JV Carlos Villar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -22.90278, lon: -43.2075, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-02-14, uploadDate: 2024-03-19T19:03, filename: Prot_000.pdf, size: 1319333, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-02-14, uploadDate: 2024-03-19T18:18, filename: ICF_001.pdf, size: 392791, hasResults: False