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

NCT03191162 | Completed Phase 2

• 1 other identifier: 2016-003789-21
• Study Type: interventional
• Target: 238
• Locations: 4 countries
• Sites: 7

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.

Conditions

Chagas Disease; Trypanosoma Cruzi Infection

Keywords

Benznidazole; PCR

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

B300/60

ACTIVE COMPARATOR

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

Drug: Benznidazole

B150/60

EXPERIMENTAL

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

Drug: Benznidazole

B400/15

EXPERIMENTAL

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

Drug: Benznidazole

Interventions

Benznidazole DRUG

To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease

Also known as: Abarax

B150/60; B300/60; B400/15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old.
• Diagnosis of Chagas disease through two different serological tests.
• Positive T. cruzi PCR in peripheral blood.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (7)

Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)

Buenos Aires, Argentina

Location

Instituto de Cardiología de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Location

Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)

Belo Horizonte, Brazil

Location

Hospital Universitário Clemente de Faria

Montes Claros, Brazil

Location

Fundación Cardioinfantil - Instituto de Cardiología

Bogotá, Colombia

Location

Centro Atencion y Diagnóstico de Enfermedades Infecciosas

Bucaramanga, Colombia

Location

Infectious Disease Department Vall d'Hebron Hospital

Barcelona, Spain

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Chagas Disease

Interventions

benzonidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Israel Molina, PhD

  Hospital Universitario Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 19, 2017
• Study Start: April 21, 2017
• Primary Completion: September 21, 2020
• Study Completion: March 16, 2021
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

AR (2); BR (2); ES (1); CO (2)