The InFACT H1N1 Clinical Trials Initiative
Randomized clinical trials are the most reliable method of evaluating the efficacy and harms associated with clinical therapies. We seek to identify inexpensive, effective, and readily available treatments that can reduce the severity of illness for patients with severe H1N1 disease, and that can assure the optimal use of scarce resources during a pandemic. We intend to initiate several randomized clinical trials that will evaluate promising agents, that will be run in parallel using comparable entry criteria, and that will use adaptive designs to expedite the transfer of this knowledge to the bedside. Through this site, the Clinical Trials Working Group will provide links to ongoing investigator-led studies on severe H1N1 infection, updates on the status of ongoing clinical trials, and template protocols that can be used to initiate new studies.
Clinical trials evaluating the efficacy of statins will be launched shortly in the United States (Gordon Bernard MD, Principle Investigator), and of corticosteroids in France (Djillali Annane MD PhD, Principle Investigator).
As of January 31, 2010, worldwide more than 209 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 15,174 deaths.