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Volume 31, Number 2—February 2025
Online Report

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

Josephine BournerComments to Author , Michel Vaillant, Alex Paddy Abdel Salam, Marie Jaspard, Camille Fritzell, Shevin T. Jacob, Tom E. Fletcher, Michael Ramharter, Nnennaya Ajayi, Sylvanus Okogbenin, Cyril Erameh, Donald Grant, Robert Samuels, Oladele Oluwafemi Ayodeji, Armand Sprecher, Bronner P. Gonçalves, Tansy Edwards, Piero Olliaro, and the WALC Work Package 2 Working Group
Author affiliation: University of Oxford, Oxford, UK (J. Bourner, A.P.A. Salam, B.P. Gonçalves, P. Olliaro); Luxembourg Institute of Health, Strassen, Luxembourg (M. Vaillant); Sorbonne Université, Paris, France (M. Jaspard); St Antoine Hospital, Paris (M. Jaspard); The Alliance for International Medical Action, Dakar, Senegal (M. Jaspard); Inserm, Bordeaux, France (C. Fritzell); Liverpool School of Tropical Medicine, Liverpool, UK, S.T. Jacob, T.E. Fletcher); University Medical Center Hamburg-Eppendorf, Hamburg, Germany (M. Ramharter); German Center for Infection Research, Riems, Germany (M. Ramharter); Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria (N. Ajayi); Irrua Specialist Teaching Hospital, Irrua, Nigeria (S. Okogbenin, C. Erameh); Kenema General Hospital, Kenema, Sierra Leone (D. Grant, R. Samuels); Federal Medical Centre, Owo, Nigeria (O.O. Ayodeji); Médecins sans Frontières, Brussels, Belgium (A. Sprecher); London School of Hygiene and Tropical Medicine, London, UK (T. Edwards)

Main Article

Table 3

Criteria for the inclusion or exclusion in future clinical trials for Lassa fever

Criteria
Inclusion criteria: all patients must meet criteria to be included in the trial
Reverse transcription PCR confirmation of Lassa fever
Adult participants (persons who had attained the age of majority according to national regulations in their country of enrollment)
Exclusion criteria: patients who meet any of the criteria will be excluded from the trial
Patients receiving end-of-life care for another illness
Involvement in another clinical trial
Unwilling to provide informed consent
History of allergic reaction or other contraindication to trial drugs
Received drug therapy for Lassa fever (excluding supportive care) before inclusion

Main Article

Page created: January 15, 2025
Page updated: January 21, 2025
Page reviewed: January 21, 2025
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