A phase-2, randomized, multicenter, placebo-controlled, proof-of-concept trial of oral fexinidazole in adults with chronic indeterminate Chagas disease

by Torrico F, Gascón J, Ortiz L, Pinto J, Rojas G, Palacios A, Barreira F, Blum B, Gabriel Schijman AG, Vaillant M, Strub-Wourgaft N, Pinazo MJ, Bilbe G, Ribeiro I, on behalf of the FEXI-CHAGAS study group. Clinical Infectious Diseases 2022; ciac579. doi: 10.1093/cid/ciac579

Summary: Pre-clinical data for the sleeping sickness treatment fexinidazole has shown efficacy against the causative agent of Chagas disease, T. cruzi, and a lack of genotoxicity. The authors describe a double-blind, randomised, placebo-controlled study of this potential treatment for Chagas disease, conducted in Bolivia. Six regimens were tested: 1200 or 1800 mg fexinidazole per day for 2, 4, or 8 weeks. Enrolment was interrupted after 4/47 patients presented with transient asymptomatic grade-3 and 4 neutropenia, while rapid, sustained clearance of parasitemia was observed in all treated patients with available data, varying between 66.7% (1200 mg, 2 weeks) and 100.0% (1800 mg, 2 weeks). Further exploratory exposure-response analysis suggested that low dosages of fexinidazole may be safe and effective.

This article is an ‘accepted manuscript’ and is not yet in its final published form.

The post A phase-2, randomized, multicenter, placebo-controlled, proof-of-concept trial of oral fexinidazole in adults with chronic indeterminate Chagas disease first appeared on DNDi.

Ayuda a los pacientes desatendidos

Hasta la fecha, hemos desarrollado nueve tratamientos para enfermedades desatendidas, salvando millones de vidas. Nuestro objetivo es poner a disposición 25 nuevos tratamientos en nuestros primeros 25 años. ¡Nos puedes ayudar!

Organización internacional sin fines de lucro que desarrolla tratamientos seguros, efectivos y asequibles para los pacientes más desatendidos.

DNDi Global

Contáctenos

DNDi en el mundo

Apoye la DNDi

¡Haga una donación!

Trabaje con nosotros

Oportunidads

A excepción de imágenes, películas y marcas comerciales que están sujetas a los Términos de uso de la DNDi, el contenido de este sitio tiene una licencia Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International license.