An observational study in Infectious Disease, sponsored by University of Minnesota. Recruiting at 56 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University of Minnesota · Observational
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 228 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be enrolled at study sites globally. Study personnel at the enrolling site will confirm eligibility and obtain consent prior to beginning study procedures. Signing of the informed consent document signifies study entry and Study Day 0. The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. All participants will meet the eligibility criteria below. Specific studies executed with this master protocol may narrow the eligibility criteria to a more specific population (that is, a subset of patients who meet the eligibility criteria in this overarching protocol).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection.
Other: No intervention
This is an observational study
Day 28 Mortality
All-cause mortality
Time frame: Day 28
Days to recovery scale (DRS)
The Days to Recovery Scale (DRS) is an ordinal ranked outcome that includes the concepts of mortality and time to recovery, with recovery defined as being discharged from the hospital and reaching home for the duration of the follow- up. At the end of the follow-up period, each patient is classified into one of the DRS categories based on vital status, hospitalization status, and duration it took to reach recovery.
Time frame: Day 28
Time to Sustained Recovery
Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.
Time frame: Day 28
Ordinal outcome for clinical improvement - Day 7
For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
Time frame: Day 7
Organ support free days
the number of days between enrollment and hospital discharge or day 28 that the participant did not receive support for some organ (lungs, kidneys, etc.)
Time frame: Day 28
The Sequential Organ Failure Assessment (SOFA) score - Day 28
The SOFA score is one of the most widely used scoring systems in critically ill patients and has also been validated in hospitalized patients with suspected infection outside the ICU. This score assesses organ dysfunction across 6 organ systems. To facilitate use of the SOFA score across a broad range of sites, including those in low- and-middle income countries (LMICs), SpO2 may be substituted for PaO2, and the presence of scleral icterus or jaundice may be substituted for serum bilirubin level . Only clinically available data will be used to calculate SOFA scores. Laboratory tests will not be completed by the study to calculate SOFA scores.
Time frame: Day 28
Started Aug 2025 (actual). Primary completion is estimated for Jun 2027, 21 months after the start.
Of 128 non-industry observational studies under Communicable Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 77. This study's planned 21 months is below that.
Counting every sponsor, half of 142 studies reached it within 37 months; a quarter within 17 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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