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

不同剂量苯并咪唑治疗成人慢性期恰加斯病的疗效及安全性评估(MULTIBENZ研究):多中心随机Ⅱ期非劣效性临床试验研究方案

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作者:D Molina-Morant, M L Fernández, P Bosch-Nicolau, E Sulleiro, M Bangher, F Salvador, A Sanchez-Montalva, A L P Ribeiro, A M B de Paula, S Eloi, R Correa-Oliveira, J C Villar, S Sosa-Estani, I Molina

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.

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.

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