Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial in hibernation, ready for rapid activation
Lim W, Brittain C, Duley L, Edwards S, Gordon S, Montgomery A, Nguyen-Van-Tam J, Read R, Whitham D, Whynes D, Woodhead M, Wootton D
Record ID 32015000311
English
Authors' objectives:
To (1) evaluate whether or not low-dose corticosteroids given as an adjunct to standard treatment is beneficial in patients who are hospitalised with severe pandemic influenza and (2) develop an 'off-the-shelf' clinical trial that is ready to be activated in a future pandemic.
Authors' recommendations:
This study demonstrates that advance set-up of a trial to be conducted during a pandemic, with full regulatory approvals in place, is possible. Regular review during the hibernation phase will be required. This study serves as a model for the development of other 'off-the-shelf' trials as part of preparedness planning for public health emergencies.
Details
Project Status:
Completed
Year Published:
2015
URL for published report:
http://www.journalslibrary.nihr.ac.uk/hta/hta19160/#/abstract
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
England, United Kingdom
MeSH Terms
- Humans
- Influenza, Human
- Pandemics
- Randomized Controlled Trial
- Clinical Protocols
- Global Health
- Steroids
- Anti-Inflammatory Agents
- Adjuvants, Pharmaceutic
Contact
Organisation Name:
NIHR Health Technology Assessment programme
Contact Address:
NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name:
journals.library@nihr.ac.uk
Contact Email:
journals.library@nihr.ac.uk
Copyright:
Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.