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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 2

Conditions: Chagas Disease; Trypanosoma Cruzi Infection

Treatments: Drug: Benznidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03191162

2016-003789-21

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 3 patient groups

B300/60

Active Comparator group

Description:

Benznidazole 300mg/day p.o. divided in two doses for 60 days

Treatment:

Drug: Benznidazole

B150/60

Experimental group

Description:

Benznidazole 150mg/day p.o. divided in two doses for 60 days

Treatment:

Drug: Benznidazole

B400/15

Experimental group

Description:

Benznidazole 400mg/day p.o. divided in two doses for 15 days

Treatment:

Drug: Benznidazole