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

Conditions

Chagas Disease, Trypanosoma Cruzi Infection

Keywords

Benznidazole, PCR

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.

Bosch-Nicolau P, Fernández ML, Sulleiro E, Villar JC, Perez-Molina JA, Correa-Oliveira R, Sosa-Estani S, Sánchez-Montalvá A, Del Carmen Bangher M, Moreira OC, Salvador F, Mota Ferreira A, Eloi-Santos SM, Serre-Delcor N, Ramírez JC, Silgado A, Oliveira I, Martín O, Aznar ML, Ribeiro ALP, Almeida PEC, Chamorro-Tojeiro S, Espinosa-Pereiro J, de Paula AMB, Váquiro-Herrera E, Tur C, Molina I, MULTIBENZ Study Group.

2024-01-1131 citations

10.1016/s1473-3099(23)00629-1

New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia

Cristina Alonso‐Vega, Julio A. Urbina, Sergi Sanz, María‐Jesús Pinazo, Jimy Pinto et al. (22 authors)

BMJ Open2021-12-0136 citations

10.1136/bmjopen-2021-052897

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.

Molina-Morant D, Fernández 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.

2020-04-1544 citations

10.1186/s13063-020-4226-2

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBenznidazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Argentina, Brazil, Colombia, Spain

Outcome results

None listed