Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial.

Bruno FrancoisSimon LambdenSebastien GibotMarc DeriveAurelie OlivierValerie CuvierStephan WitteJean-Marie GrouinJean Jacques GaraudMargarita Salcedo-MagguilliMitchell LevyPierre-François Laterre

Published in: BMJ open (2021)

The study has been approved by the responsible ethics committees/institutional review boards in all study countries: Belgium: Universitair Ziekenhuis Antwerpen, France: CPP Ile de France II, Denmark: Region Hovedstaden, Spain: ethics committee from Valld'Hebron Hospital, Barcelona, Finland: Tukija, Ireland: St. James' Hospital (SJH) / Tallaght University Hospital (TUH) Joint Research Ethics Committee, USA: Lifespan, Providence TRIAL REGISTRATION NUMBERS: EudraCT Number: 2018-004827-36 and NCT04055909.

Keyphrases

public health
septic shock
study protocol
healthcare
randomized controlled trial
global health
open label