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Completed

NCT Number: NCT03191162

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

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.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosoma Cruzi Infection Trypanosomiasis Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benznidazole

Drug

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

Other names: Abarax

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: MULTIBENZ

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 19, 2017
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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