Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics.

• Tác giả: Alex Paddy Abdel Salam, Nnennaya Ajayi, Oladele Oluwafemi Ayodeji, Josephine Bourner, Tansy Edwards, Cyril Erameh, Tom E Fletcher, Camille Fritzell, Bronner P Gonçalves, Donald Grant, Shevin T Jacob, Marie Jaspard, Sylvanus Okogbenin, Piero Olliaro, Michael Ramharter, Robert Samuels, Armand Sprecher, Michel Vaillant
• Ngôn ngữ: eng
• Thông tin xuất bản: United States : Emerging infectious diseases , 2025
• Bộ sưu tập: NCBI
• ID: 482064

Tóm tắt

 The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates
  however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.