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Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

Study acronym: NuestroBen
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 30, 2023 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 3 of 6 sitesv4
  2. Primary completion date: Feb 2023 to Jun 1, 2026v3 Show 10 more changesShow less
    • Enrollment target: 362 to 300
    • Study completion date: Feb 2023 to Dec 1, 2026
    • Interventions: Short regimen of benznidazole (Drug), Standard treatment with benznidazole (Drug) to Short regimen of benznidazole (Drug), Short treatment with benznidazole (Drug), Standard treatment with benznidazole (Drug)
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 8 words
    • Site contacts updated at 1 of 6 sites
    • Collaborator revised
    • Study arms: 2 to 3
    • Study title expanded, about 5 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2021 to Jul 28, 2021
    • Site details revised at 6 of 6 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.
Trial Details
NCT Number NCT04897516
Lead Sponsor Laboratorio Elea Phoenix S.A.
Collaborators: Drugs for Neglected Diseases
Conditions
(from sponsor)		 Chagas Disease
Related terms Chagas Disease
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov