STRIVE002

• Research type

  Research Study

• Full title

  An International Observational Study of Adults with Acute Infection

• IRAS ID

  348037

• Contact name

  Sarah Pett

• Contact email

  s.pett@ucl.ac.uk

• Sponsor organisation

  Reagents of the University of Minnesota

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  STRIVE-002 is an observational prospective clinical platform (master) study with enrolment of adult participants aged 18 years and older who are hospitalised with an acute infection or have developed the longer-term consequence of an acute infection (‘long-X syndrome). It is part of global epidemic/pandemic preparedness. The master protocol describes the overall aims alongside study-specific appendices that describe discrete studies focussed on specific infections/syndromes of interest. Clinical data and biospecimens will be collected from enrolled participants with an overarching goal of rapidly advancing our understanding of emerging acute infections globally over time using the same study protocol.
  This master protocol design will enable investigators to focus enrolment on acute infections with the greatest public health threat at a particular time. Importantly, the focus of the study can pivot in response to emerging infection-related public health priorities in different parts of the world (where the STRIVE network has sites) by opening different study-specific appendices. Specific appendices give the details, including specific eligibility criteria, the relevant data and biospecimen collection according to a tier system 1-4. The tiers are defined according to the number and type of specimens, the collection timepoints for these specimens and the clinical data from participants. Flexibility has been built in to facilitate remote specimen and clinical data collection.

  At this time, only Appendix A, IC-SARI, is being opened for enrolment.
  IC-SARI is enrolling immunocompromised (IC) patients hospitalised with severe acute respiratory illness (SARI), following them for 60 days with a tier 3 specimen/data collection schedule. There is no randomisation as this is an observational platform. There are no medications being assessed, and all participants are managed according to standard-of-care with no restrictions.
  Each successive Appendix (i.e. Appendix B, C etc) within STRIVE-002 will be considered as an amendment.
  

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  25/YH/0146

• Date of REC Opinion

  10 Oct 2025

• REC opinion

  Further Information Favourable Opinion