STRIVE002
Immuno-Compromised Severe Acute Respiratory Infection (IC-SARI) study
Severe acute respiratory infection (SARI) remains an important cause of illness and hospitalisation worldwide, but there are still limited data on the pathogens causing SARI in immunocompromised adults and on how outcomes may vary by the type of immunocompromising condition, host factors, or geographic region. The need for better prospective data is particularly important because immunocompromised adults are a heterogeneous group and may experience different patterns of susceptibility, disease severity, and recovery.
IC-SARI is an observational, multicentre, multinational prospective cohort study conducted under the STRIVE observational master protocol. The study will enrol adults with a moderate-to-severe immunocompromising condition who are hospitalised with severe acute respiratory infection (SARI). By describing the pathogens causing infection, the clinical course, and outcomes in this high-risk population, the study will generate prospective data to fill an important evidence gap and help inform the design of future prevention and treatment studies, including clinical trials.
This is a minimal-risk observational study. Participants are enrolled during hospitalisation and followed through their admission and again after discharge for up to 60 days. The study collects routine clinical information, patient-reported outcomes, and selected biospecimens to characterise infection and host response. In hospital, data are collected through interviews and medical record review, with samples such as blood, nasal swabs, urine, sputum, and tracheal aspirate collected where appropriate; follow-up may be completed remotely after discharge.
This is an ongoing study and results are not yet available.
The study will help fill an important evidence gap by providing global prospective data on SARI in immunocompromised adults. These findings should improve understanding of disease patterns and outcomes in this population and help guide the development of future clinical trials and therapeutic strategies.
- University of Minnesota, Clinical and Translational Science Institute – Minnesota, USA
- Copenhagen HIV Program (CHIP) – Copenhagen, Denmark
- Medical Research Council (MRC) CTU at University College London (UCL) – London, United Kingdom
- The Institute for Clinical Research at the Veterans Affairs Medical Center – Washington, D.C, USA
- Hennepin Medical Center – Minneapolis, Minnesota, USA
- Mount Sinai Medical Center, New York – New York, USA
- Vanderbilt University Medical Center – Nashville, Tennessee, USA
- US Department of Veterans Affairs – USA
- Inserm-ANRS – France
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
