Clinical trial NCT03191162: Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chagas Disease
Trypanosoma Cruzi Infection
Keywords: Benznidazole
PCR
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
city: Corrientes
country: Argentina
facility: Instituto de Cardiología de Corrientes Juana Francisca Cabral
city: Belo Horizonte
country: Brazil
facility: Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
city: Montes Claros
country: Brazil
facility: Hospital Universitário Clemente de Faria
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil - Instituto de Cardiología
city: Bucaramanga
country: Colombia
facility: Centro Atencion y Diagnóstico de Enfermedades Infecciosas
city: Barcelona
country: Spain
facility: Infectious Disease Department Vall d'Hebron Hospital
Study officials:
affiliation: Hospital Universitario Vall d'Hebron Research Institute
name: Israel Molina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.