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

Chagas Disease Clinical Trial

— MULTIBENZ  

Official title:

Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191162
• Other study ID #: 2016-003789-21
• Status: Completed
• Phase: Phase 2
• Start date: April 21, 2017
• Est. completion date: March 16, 2021

Study information

• Verified date: December 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 16, 2021
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chagas Disease
• Trypanosoma Cruzi Infection

Intervention

Drug:
• Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease

Locations

Country	Name	City	State
Argentina	Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)	Buenos Aires
Argentina	Instituto de Cardiología de Corrientes Juana Francisca Cabral	Corrientes
Brazil	Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)	Belo Horizonte
Brazil	Hospital Universitário Clemente de Faria	Montes Claros
Colombia	Fundación Cardioinfantil - Instituto de Cardiología	Bogotá
Colombia	Centro Atencion y Diagnóstico de Enfermedades Infecciosas	Bucaramanga
Spain	Infectious Disease Department Vall d'Hebron Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment	The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment	12 months