Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

Phase 2

Completed

• Conditions: Chagas Disease; Trypanosoma Cruzi Infection
• Interventions: Drug: Benznidazole

• Registration Number: NCT03191162
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Primary Completion: 2020-09-21
• Study Completion: 2021-03-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Over 18 years old.
• Diagnosis of Chagas disease through two different serological tests.
• Positive T. cruzi PCR in peripheral blood.
• Signed informed consent.

Exclusion Criteria

• Previous treatment with Benznidazole or Nifurtimox.
• Alcohol consumption.
• Acute or chronic health problems that could interfere in the assessment of the efficacy or safety of the drug (acute infections, HIV infection, liver or renal impairment, etc).
• Nitroimidazole hipersensitivity.
• Concomitant or previous treatment with allopurinol or antifungal drugs.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B300/60	Benznidazole	Benznidazole 300mg/day p.o. divided in two doses for 60 days
B150/60	Benznidazole	Benznidazole 150mg/day p.o. divided in two doses for 60 days
B400/15	Benznidazole	Benznidazole 400mg/day p.o. divided in two doses for 15 days

Primary Outcome Measures

Name	Time	Method
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment	12 months	The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment

Trial Locations

Locations (7)

Infectious Disease Department Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain

Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ); 🇧🇷 Belo Horizonte, Brazil

Hospital Universitário Clemente de Faria; 🇧🇷 Montes Claros, Brazil

Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS); 🇦🇷 Buenos Aires, Argentina

Fundación Cardioinfantil - Instituto de Cardiología; 🇨🇴 Bogotá, Colombia

Centro Atencion y Diagnóstico de Enfermedades Infecciosas; 🇨🇴 Bucaramanga, Colombia

Instituto de Cardiología de Corrientes Juana Francisca Cabral; 🇦🇷 Corrientes, Argentina