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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chagas Disease, Trypanosoma Cruzi Infection

Intervention / Treatment
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* Drug: Benznidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benznidazole, PCR