Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT07069400

Conditions

Infectious Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

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.

Conditions

Infectious Disease

Study ID

NCT07069400

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Jun 8, 2027

Anticipated

Primary completion date

Jun 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group

The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection.

Interventions

No intervention

This is an observational study

Primary outcome measure

  • Day 28 Mortality [ Time Frame: Day 28 ]
  • Days to recovery scale (DRS) [ Time Frame: Day 28 ]
  • Time to Sustained Recovery [ Time Frame: Day 28 ]
  • Ordinal outcome for clinical improvement - Day 7 [ Time Frame: Day 7 ]
  • Organ support free days [ Time Frame: Day 28 ]
  • The Sequential Organ Failure Assessment (SOFA) score - Day 28 [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Locations

Banner University Medical Center Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Stanford University Hospital & Clinics (Site 203-003)

Recruiting

Palo Alto, California, United States, 94305

Contacts

UCSF Medical Center (Site 203-001)

Recruiting

San Francisco, California, United States, 94143

Contacts

Orlando VA Medical Center (074-032)

Recruiting

Orlando, Florida, United States, 32827

Contacts

University of Illinois at Chicago (Site 008-012)

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Lutheran Medical Group

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

University of Kansas Medical Center (Site 080-044)

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Mayo Clinic (Site 054-001)

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

University of Nebraska Medical Center (Site 080-045)

Recruiting

Omaha, Nebraska, United States, 68198-5400

Contacts

New York University Langone Health (301-013)

Recruiting

New York, New York, United States, 10016

Contacts

Mount Sinai Medical Center (Site 301-012)

Recruiting

New York, New York, United States, 11234

Contacts

Duke University (301-006)

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Wake Forest Baptist Health (210-001)

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Cleveland Clinic Foundation (Site 207-001)

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Vanderbilt University Medical Center (Site 212-001)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

UT Southwestern Medical Center (084-001)

Recruiting

Dallas, Texas, United States, 75390

Contacts

MEDVAMC (Site 074-006)

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Intermountain Medical Center (Site 211-001)

Recruiting

Murray, Utah, United States, 84107

Contacts

West Virginia University Medicine (301-023)

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-27.