Severe acute respiratory infections (SARI)

The University of Minnesota (UMN)

For France: Florence ADER, MD, PhD, Hospices Civils de Lyon, Hôpital de la Croix Rousse

This study is an observational prospective clinical study with enrollment of adult participants hospitalized with an acute infection. Data and biospecimens will be collected from enrolled participants 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. The protocol was developed by the Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE) Network. It is designed to enroll participants globally using a shared protocol and data and biospecimen collection methods.

The protocol is designed to be a minimal risk research study, meaning that study participants will not be exposed to substantive incremental risk as a result of study procedures.

The protocol is designed to facilitate the study of a broad array of acute infectious diseases over time using the same study protocol. The protocol is structured with a master protocol that describes overarching goals and study procedures, plus study-specific appendices that describe discrete studies that will use the overarching framework of the master protocol. These study appendices define specific eligibility criteria and study procedures that will be used to enroll participants. Each appendix may be analyzed as a separate study or data generated using different appendices may be pooled for analysis. New appendices may be added to the protocol in the future. This master protocol design will enable investigators to focus enrollment on acute infections with the greatest public health threat at a particular time and change the focus of the study as public health priorities change by opening different study-specific appendices.

Observational, multicenter, multinational prospective cohort study conducted using the STRIVE observational master protocol

The overarching goal of this study is to advance knowledge on the pathogens most commonly causing SARI among immunocompromised adults globally and on the clinical outcomes of patients with these infections. Specific objectives include:

1. Describe the distribution of pathogens causing SARI among hospitalized immunocompromised adults,
2. Describe the distribution of immunocompromising conditions among immunocompromised adults hospitalized with SARI,
3. Describe clinical outcomes among immunocompromised adults hospitalized with SARI: (a) overall, (b) by immunocompromising condition, (c) by detected pathogen, and (d) by host factors.

Overall mortality

Days to Recovery Scale with 60 days of follow-up (DRS-60)

Time to Sustained Recovery

WHO Ordinal Scale for Clinical Improvement

Sequential Organ Failure Assessment (SOFA) score

Patient Reported Outcomes (EQ-5D-5L, CAP-Sym, Borg dyspnea scale (CR10))

Biospecimen collection

Adults with a moderate-to-severe immunocompromising condition hospitalized for SARI

–

1500

21 countries, 59 sites

–

–

Study coordination and monitoring

https://clinicaltrials.gov/study/NCT07069400