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

Autor: Molina-Morant, D., Fernández, M. L., Bosch-Nicolau, Pau, Sulleiro, Elena, Bangher, M., Salvador, F., Sanchez-Montalva, A., Ribeiro, A. L. P., de Paula, A. M. B., Eloi, S., Correa-Oliveira, Rodrigo, Villar, J. C., Sosa-Estani, S., Molina Romero, Israel, Universitat Autònoma de Barcelona
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Chagas disease
Medicine (miscellaneous)
Aftercare
Parasite Load
Study Protocol
0302 clinical medicine
purl.org/becyt/ford/3.2 [https]
Pharmacology (medical)
media_common
0303 health sciences
lcsh:R5-920
Standard treatment
Neglected Diseases
CLINICAL TRIAL
Trypanocidal Agents
THERAPEUTIC
Multicenter study
Clinical trial
Treatment Outcome
Tolerability
Benznidazole
Nitroimidazoles
Female
purl.org/becyt/ford/3 [https]
Safety
Therapeutic
lcsh:Medicine (General)
Brazil
medicine.drug
Drug
Adult
medicine.medical_specialty
Randomization
BENZNIDAZOLE
media_common.quotation_subject
Trypanosoma cruzi
030231 tropical medicine
Argentina
Colombia
03 medical and health sciences
Pharmacokinetics
Double-Blind Method
Internal medicine
medicine
Humans
030306 microbiology
business.industry
CHAGAS DISEASE
Regimen
Spain
Case-Control Studies
Chronic Disease
MULTICENTER STUDY
business
Zdroj: Trials, Vol 21, Iss 1, Pp 1-10 (2020)
CONICET Digital (CONICET)
Consejo Nacional de Investigaciones Científicas y Técnicas
instacron:CONICET
Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-4226-2
Popis: Background: Chagas disease (CD) continues to be a neglected infectious disease with one of the largest burdens globally. Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice. Its current recommended dose is based on nonrandomized studies, and efficacy and safety of the optimal dose of BNZ have been scarcely analyzed in clinical trials.Methods/design: MULTIBENZ is a phase II, randomized, noninferiority, double-blind, multicenter international clinical trial. A total of 240 patients with Trypanosoma CD in the chronic phase will be recruited in four different countries (Argentina, Brazil, Colombia, and Spain). Patients will be randomized to receive BNZ 150 mg/day for 60 days, 400 mg/day for 15 days, or 300 mg/day for 60 days (comparator arm). The primary outcome is the efficacy of three different BNZ therapeutic schemes in terms of dose and duration. Efficacy will be assessed according to the proportion of patients with sustained parasitic load suppression in peripheral blood measured by polymerase chain reaction. The secondary outcomes are related to pharmacokinetics and drug tolerability. The follow-up will be 12 months from randomization to end of study participation. Recruitment was started in April 2018.Conclusion: This is a clinical trial conducted for the assessment of different dose schemes of BNZ compared with the standard treatment regimen for the treatment of CD in the chronic phase. MULTIBENZ may help to clarify which is the most adequate BNZ regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood. Fil: Molina Morant, D.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Fernández, M. L.. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; Argentina Fil: Bosch Nicolau, P.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Sulleiro, E.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Bangher, M.. Instituto de Cardiologia de Corrientes Juana Francisca Cabral.; Argentina Fil: Salvador, F.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Sanchez Montalva, A.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España Fil: Ribeiro, A.L.P.. Universidade Federal de Minas Gerais; Brasil Fil: De Paula, A.M.B.. Universidad Federal de Montes Claros; Brasil Fil: Eloi, S.. Universidade Federal de Minas Gerais; Brasil Fil: Oliveira Correa, Ronaldo. Fundación Oswaldo Cruz; Brasil Fil: Villar, J. C.. Instituto de Cardiología; Colombia Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Molina, I.. Universidad Autónoma de Barcelona. Hospital Vall D' Hebron; España
Databáze: OpenAIRE
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