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

December 18, 2023 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B300/60
Benznidazole 300mg/day p.o. divided in two doses for 60 days
Drug: Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Other Names:
  • Abarax
Experimental: B150/60
Benznidazole 150mg/day p.o. divided in two doses for 60 days
Drug: Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Other Names:
  • Abarax
Experimental: B400/15
Benznidazole 400mg/day p.o. divided in two doses for 15 days
Drug: Benznidazole
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Other Names:
  • Abarax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Israel Molina, PhD, Hospital Universitario Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2017

Primary Completion (Actual)

September 21, 2020

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-003789-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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