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RECRUITING
NCT04897516
PHASE3

Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

Sponsor: Laboratorio Elea Phoenix S.A.

View on ClinicalTrials.gov

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.

Official title: Phase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-07-28

Completion Date

2026-12-01

Last Updated

2023-11-30

Healthy Volunteers

No

Conditions

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

Locations (6)

Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben"

Buenos Aires, Argentina

Fundación Huésped

Buenos Aires, Argentina

Hospital Francisco Javier Muñiz

Buenos Aires, Argentina

Hospital Donación Francisco Santojanni

Buenos Aires, Argentina

Instituto de Cardiología de Corrientes "Juana Francisca Cabral"

Corrientes, Argentina

Centro de Chagas y Patología Regional, Hospital Independencia

Santiago del Estero, Argentina