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2.
Trials ; 21(1): 328, 2020 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-32293523

RESUMEN

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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03191162. Registered on 19 June 2017.


Asunto(s)
Enfermedad de Chagas/tratamiento farmacológico , Enfermedades Desatendidas/parasitología , Nitroimidazoles/uso terapéutico , Tripanocidas/uso terapéutico , Trypanosoma cruzi/aislamiento & purificación , Adulto , Cuidados Posteriores , Argentina/epidemiología , Brasil/epidemiología , Estudios de Casos y Controles , Enfermedad de Chagas/parasitología , Enfermedad Crónica , Colombia/epidemiología , Método Doble Ciego , Femenino , Humanos , Masculino , Nitroimidazoles/farmacocinética , Carga de Parásitos/estadística & datos numéricos , Seguridad , España/epidemiología , Resultado del Tratamiento , Tripanocidas/farmacocinética , Trypanosoma cruzi/genética
3.
Int J Infect Dis ; 78: 103-106, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30391324

RESUMEN

There is little published data on benznidazole dosing, or levels in cerebrospinal fluid. In this report, we describe the clinical course of an immunosuppressed patient with Chagas central nervous system involvement. He was treated successfully with larger benznidazole doses than are recommended, in order to reach therapeutically effective concentrations in the brain.


Asunto(s)
Encéfalo/metabolismo , Enfermedad de Chagas/inmunología , Inmunosupresores/administración & dosificación , Trasplante de Riñón , Nitroimidazoles/administración & dosificación , Humanos , Huésped Inmunocomprometido , Masculino , Persona de Mediana Edad , Nitroimidazoles/farmacocinética
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