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

Primary Purpose

Chagas Disease, Trypanosoma Cruzi Infection

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Benznidazole
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease focused on measuring Benznidazole, PCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
  • Instituto de Cardiología de Corrientes Juana Francisca Cabral
  • Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
  • Hospital Universitário Clemente de Faria
  • Fundación Cardioinfantil - Instituto de Cardiología
  • Centro Atencion y Diagnóstico de Enfermedades Infecciosas
  • Infectious Disease Department Vall d'Hebron HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

B300/60

B150/60

B400/15

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2017
Last Updated
June 16, 2017
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03191162
Brief Title
Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
Acronym
MULTIBENZ
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease, Trypanosoma Cruzi Infection
Keywords
Benznidazole, PCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B300/60
Arm Type
Active Comparator
Arm Description
Benznidazole 300mg/day p.o. divided in two doses for 60 days
Arm Title
B150/60
Arm Type
Experimental
Arm Description
Benznidazole 150mg/day p.o. divided in two doses for 60 days
Arm Title
B400/15
Arm Type
Experimental
Arm Description
Benznidazole 400mg/day p.o. divided in two doses for 15 days
Intervention Type
Drug
Intervention Name(s)
Benznidazole
Other Intervention Name(s)
Abarax
Intervention Description
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Primary Outcome Measure Information:
Title
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Description
The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israel Molina, PhD
Phone
0034 93 274 6251
Email
imolina@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Salvador, MD
Phone
0034 93 274 6251
Email
fmsalvad@vhebron.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Molina, PhD
Organizational Affiliation
Hospital Universitario Vall d'Hebron Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Fernández
Facility Name
Instituto de Cardiología de Corrientes Juana Francisca Cabral
City
Corrientes
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria del Carmen Bangher
Facility Name
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
City
Belo Horizonte
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Correa Oliveira
Facility Name
Hospital Universitário Clemente de Faria
City
Montes Claros
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Luiz Pinho Ribeiro
Facility Name
Fundación Cardioinfantil - Instituto de Cardiología
City
Bogotá
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Villar
Facility Name
Centro Atencion y Diagnóstico de Enfermedades Infecciosas
City
Bucaramanga
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Marina Rojas
Facility Name
Infectious Disease Department Vall d'Hebron Hospital
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molina Israel, MD
First Name & Middle Initial & Last Name & Degree
Molina Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32293523
Citation
Molina-Morant D, Fernandez ML, Bosch-Nicolau P, Sulleiro E, Bangher M, Salvador F, Sanchez-Montalva A, Ribeiro ALP, de Paula AMB, Eloi S, Correa-Oliveira R, Villar JC, Sosa-Estani S, Molina I. Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial. Trials. 2020 Apr 15;21(1):328. doi: 10.1186/s13063-020-4226-2.
Results Reference
derived

Learn more about this trial

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

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