STRIVE 002

STRIVE observational study protocol: An International Observational Study of Adults with Acute Infection (STRIDE (STRIVE 002))

An International Observational Study of Adults with Acute Infection

What is this study about?

STRIVE 002 is an observational prospective clinical study with enrolment of adult participants hospitalised with an acute infection.

This observational protocol has been developed by the Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE) Network, with an overarching goal to advance our understanding of the epidemiology and pathobiology of severe acute infections, placing humans at risk for morbidity and mortality.

 STRIVE 002 is a master protocol designed to facilitate discrete observational studies using a common framework. The study procedures will collect longitudinal data and biological samples from hospitalised adults with acute infections with known or emerging pathogens. STRIVE 002 may include studies in respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging/re-emerging infectious diseases.

The overarching objectives of this study are to:

  • Describe demographic data and perform pathogenic diagnostics for acute infections of interest
  • Characterise clinical features, including reportable outcomes and prognostic factors associated with better or worse clinical outcomes, and estimate the association between specific therapies and patient outcomes
  • Determine the mortality percentage and percentage who develop other adverse outcomes during or following hospitalisation, factoring in temporal, spatial, and patient subset variables
  • Investigate host and pathogen risk factors via measurement of biomarkers and evaluate their association with clinical outcomes

Type of study

Observational study

Contact details

mrcctu.icsari@ucl.ac.uk

Data Sharing

The Statistical and Data Management Centre (SDMC) at the University of Minnesota (UMN) is responsible for sharing the data collected as part of the trial.

Who is funding the study?

The study is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health (USA).

When is it taking place?

The study opened in 2025 and will run for at least 3 years.

Where is it taking place?

The study is being conducted in Africa, North and South America, Asia, Australia, and Europe. Sites under the remit of the MRC CTU at UCL (acting as an International Coordinating Centre for STRIVE) are in Greece, Uganda, Zimbabwe, and the UK.

Who is included?

Adults aged 18 years or older admitted to hospital for the management of an acute infectious disease of interest.