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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03191162
Recruitment Status : Unknown
Verified June 2017 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Chagas Disease Trypanosoma Cruzi Infection Drug: Benznidazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

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 Name: 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 Name: 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 Name: Abarax




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191162


Contacts
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Contact: Israel Molina, PhD 0034 93 274 6251 imolina@vhebron.net
Contact: Fernando Salvador, MD 0034 93 274 6251 fmsalvad@vhebron.net

Locations
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Argentina
Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS) Not yet recruiting
Buenos Aires, Argentina
Contact: Marisa Fernández         
Instituto de Cardiología de Corrientes Juana Francisca Cabral Not yet recruiting
Corrientes, Argentina
Contact: Maria del Carmen Bangher         
Brazil
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ) Not yet recruiting
Belo Horizonte, Brazil
Contact: Rodrigo Correa Oliveira         
Hospital Universitário Clemente de Faria Not yet recruiting
Montes Claros, Brazil
Contact: Antonio Luiz Pinho Ribeiro         
Colombia
Fundación Cardioinfantil - Instituto de Cardiología Not yet recruiting
Bogotá, Colombia
Contact: Juan Carlos Villar         
Centro Atencion y Diagnóstico de Enfermedades Infecciosas Not yet recruiting
Bucaramanga, Colombia
Contact: Elsa Marina Rojas         
Spain
Infectious Disease Department Vall d'Hebron Hospital Recruiting
Barcelona, Spain
Contact: Molina Israel, MD         
Principal Investigator: Molina Israel         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Israel Molina, PhD Hospital Universitario Vall d'Hebron Research Institute

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03191162     History of Changes
Other Study ID Numbers: 2016-003789-21
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Benznidazole
PCR
Additional relevant MeSH terms:
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Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents