By Pinazo M-J, Forsyth C, Losada I, Esteban ET, García-Rodríguez M, Villegas ML, Molina I, Crespillo-Andújar C, Gállego M, Ballart C, Ramirez JC, Aden T, Hoerauf A, Pfarr K, Vaillant M, Marques T, Fernandes J, Blum B, Ribeiro I, Sosa-Estani S, Barreira F, Gascón J, on behalf of the FEXI-12 Study Team. The Lancet Infectious Diseases 2024. doi: 10.1016/S1473-3099(23)00651-5
Summary: In a previous trial, fexinidazole proved efficacious against Trypanosoma cruzi infection in patients with Chagas disease, but was not well tolerated. The authors of this manuscript evaluated fexinidazole at lower doses and for shorter durations in a randomised, double-blind, phase II trial. Three fexinidazole regimens were evaluated in adults: 600 mg once daily for 10 days, 1200 mg daily for 3 days, and 600 mg daily for 3 days followed by 1200 mg daily for 4 days. 8/43 fexinidazole-treated patients had sustained negative results by PCR at end of treatment and at four months follow-up, compared with 6/46 for a historical placebo control group. The regimens in this study had an acceptable safety profile but were not effective against T cruzi infection.
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