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

NCT03191162 — Phase 2, Completed, 238 participants, Hospital Universitari Vall d'Hebron Research Institute

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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

Registry	NCT03191162, acronym MULTIBENZ
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	238 (Actual)
Sponsor	Hospital Universitari Vall d'Hebron Research Institute (Other)
Conditions	Chagas Disease, Trypanosoma Cruzi Infection
Interventions	Benznidazole (Drug)
Dates	start 2017-04-21, primary completion 2020-09-21, completion 2021-03-16, first posted 2017-06-19, last updated 2023-12-19
Locations	7 sites in Argentina, Brazil, Colombia, Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
B300/60	Active comparator	Drug: Benznidazole	Benznidazole 300mg/day p.o. divided in two doses for 60 days
B150/60	Experimental	Drug: Benznidazole	Benznidazole 150mg/day p.o. divided in two doses for 60 days
B400/15	Experimental	Drug: Benznidazole	Benznidazole 400mg/day p.o. divided in two doses for 15 days

Benznidazole (Drug), also known as Abarax: To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease

+Outcome measures

Primary outcomes

Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment [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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (7)

Facility	City	Country
Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)	Buenos Aires	Argentina
Instituto de Cardiología de Corrientes Juana Francisca Cabral	Corrientes	Argentina
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)	Belo Horizonte	Brazil
Hospital Universitário Clemente de Faria	Montes Claros	Brazil
Fundación Cardioinfantil - Instituto de Cardiología	Bogotá	Colombia
Centro Atencion y Diagnóstico de Enfermedades Infecciosas	Bucaramanga	Colombia
Infectious Disease Department Vall d'Hebron Hospital	Barcelona	Spain

+Publications

Results publication: Bosch-Nicolau P, Fernandez ML, Sulleiro E, Villar JC, Perez-Molina JA, Correa-Oliveira R, Sosa-Estani S, Sanchez-Montalva A, Del Carmen Bangher M, Moreira OC, Salvador F, Mota Ferreira A, Eloi-Santos SM, Serre-Delcor N, Ramirez JC, Silgado A, Oliveira I, Martin O, Aznar ML, Ribeiro ALP, Almeida PEC, Chamorro-Tojeiro S, Espinosa-Pereiro J, de Paula AMB, Vaquiro-Herrera E, Tur C, Molina I; MULTIBENZ Study Group. Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial. Lancet Infect Dis. 2024 Apr;24(4):386-394. doi: 10.1016/S1473-3099(23)00629-1. Epub 2024 Jan 11. PMID 38218195
Results publication: 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. PMID 32293523

+Investigators

Israel Molina, PhD, Principal investigator, Hospital Universitario Vall d'Hebron Research Institute

+Funding

NIH grants: 2016

My Notes

Public

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