Observational Study of Adults with Acute Infection

This is an observational study looking at adults who are hospitalized with an acute (sudden and severe) infectious disease. Researchers want to understand more about these infections, including what causes them, how they affect people, and the best ways to manage them. You could join if you are 18 or older, admitted to the hospital (or emergency room with planned admission) for a suspected or confirmed acute infection, and your symptoms started within the last 30 days. The study will measure how many people die by day 28, how long it takes to recover, and the time until a sustained recovery (meaning you stay better). The current status of this study is unclear.

Study design
This is an observational study, meaning no specific intervention is given. It plans to include 1500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for outcomes measured at Day 28.

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NCT07069400

An International Observational Study of Adults With Acute Infection

Recruiting
Not specifiedAges 18+Observational
University of Minnesota
~1,500 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
55 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Day 28 Mortality
Measured over Day 28
+5 more outcomes measured
Infectious Disease
56 sites across 41 states
Victoria4
New South Wales3
California2
Minnesota2
New York2
North Carolina2
Texas2
Australia2
  • Cavan Reilly, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

Age ≥18 years old
Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.
Onset of symptoms of an infectious disease within the past 30 days.
Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.

Exclusion

Current imprisonment (this does not include quarantine for an infectious disease).
Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.
Expected inability or unwillingness to participate in study procedures.
In the opinion of the investigator, participation in the study is not in the best interest of the patient.
  • Day 28 MortalityDay 28

    All-cause mortality

  • Days to recovery scale (DRS)Day 28

    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 to Sustained RecoveryDay 28

    Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.

  • Ordinal outcome for clinical improvement - Day 7Day 7

    For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.

  • Organ support free daysDay 28

    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.)

  • The Sequential Organ Failure Assessment (SOFA) score - Day 28Day 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.