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Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

NCT04897516 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-11-30

No results posted yet for this study

Summary

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.

Conditions

  • Chagas Disease

Interventions

DRUG

Short regimen of benznidazole

Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.

DRUG

Short treatment with benznidazole

Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 4 weeks.

DRUG

Standard treatment with benznidazole

Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    collaborator OTHER

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Principal Investigators

  • María Jesús Pinazo, MD · Drugs for Neglected Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897516 on ClinicalTrials.gov